NutrivaGlobal | Your Indian Partner for Pharmaceutical, Health & Wellness Industry
In these economically volatile times, strategic vision is more important than ever. We provide business leaders with forward-looking business strategy consulting services that help drive sustainable competitive advantage and profitability. We deliver superior industry strategy consulting services across key areas including:
Corporate strategy and strategic planning: We work closely with clients to develop robust corporate and business unit strategies while building alignment across the organization. We provide industry-specific strategy consulting for fundamental strategic challenges such as market assessment, scenario planning, strategic planning, process design, and alliance management.
We provide strategy consulting to help your business create new sources of revenue growth. Tailoring proven best practices to your particular business and industry, we will work with you to develop world-class innovation processes, fill your innovation pipeline with new products and services, and create distinctive brand strategies. Our ability to uncover hidden consumer needs and innovate new solutions to meet those needs has driven sizable new revenues for our clients.
Our strategy consulting services can help you tap the full potential of your workforce. We offer deep expertise and experience in organizational design, including leading-edge solutions such as global business services and centers of excellence; as well as innovative approaches to leadership development, performance management, and other aspects of workforce development.
Our strategy consulting services can provide you experienced, expert support for all facets of mergers and acquisitions including target identification and screening, due diligence, and post-merger integration.
Our strategy consulting services include support for functional strategy development across all back-office operations including finance, human resources, procurement, and information technology. For example, for the finance function, we deliver hands-on support for all phases of finance outsourcing and offshoring, and our working capital management solutions have freed up millions of rupees of improved cash flow for our clients.
With medical breakthroughs, innovation, and regulatory changes, the healthcare industry today is undergoing massive disruption.
Whether you are a healthcare provider or life sciences organization, you must balance the constant tension of providing the latest advancements with the simultaneous pressure to minimize cost.
We know what it takes to strike that balance. Our healthcare consulting services can provide creative business and technology solutions to your greatest operational challenges.
We are conscious about the importance of technology transfer from development site to the manufacturing site.
We believe that successful technology transfer is critical to project success. We ensure systematic transfer of scientific information, formulation process, analytical methods and the technological basis associated with a drug product from its development site (knowledge center) to the receiving site (manufacturing plant) with a positive experience learned and realized by both sides by complying all the regulatory requirements in terms of Efficacy, Quality and Safety.
We take pride in supporting its customers by offering end to end support – the formulation and analytical scientists from contract development organization (CDO) remain present at manufacturing site for seamless execution of analytical method transfer, scale up and dossier submission batch manufacturing. As a preventive measure, analytical scientists remain present during each analysis of submission batch samples in order to ensure that there are no issues during analysis and prevent delays in dossier filing.
After submission of technology transfer docket to the manufacturing site for preparation of batch records and protocols, our team shall review and ensure correctness of all contract manufacturing organization (CMO) related documents like scale up and dossier submission batch BMRs, BPRs, stability protocols, sampling protocols, in process, finished product and stability specifications including standard test procedures (STPs) etc. for seamless transfer of technology to the manufacturing site.
We help pharmaceutical manufacturers win in a rapidly evolving market characterized by unpredictable product pipelines and uncertain regulatory actions. We bring unmatched expertise in innovation, customer experience, cost management, organizational design, M&A and other disciplines essential to achieving and maintaining industry leadership.
Globalisation and company growth ambitions are driving an increase in M&A activity worldwide.
We work with entrepreneurial businesses in the mid-market to help them assess the true commercial potential of their planned acquisition and understand how the purchase might serve their longer- term strategic goals.
Through our highly experienced team, we offer seamless access to a full range of transactional and other advisory services to ensure you get maximum value from your deals. With market-leading teams in all key financial centres, we can advise wherever you are looking to acquire.
Due to our domain expertise, all phases of projects gets completed correct first time and on time free of delays due to teething problems
“Time is money” – delayed customer orders mean profit losses and tarnished reputations. Miscommunication, disorganization, and high capability variance contribute to frustratingly long production lead times. Turnkey manufacturing services help project leaders bypass many of these issues. Since all phases of production are consolidated under one company, tasks are easier to coordinate, and streamlined communication processes prevent unnecessary misunderstandings. Tturnkey provider will always have established protocols in place to serve as the foundation for their team’s success. This systematic approach to the project workflow will boost efficiency and ensure production times are minimized. Besides, in the event of a setback, partnering with a single company instead of multiple companies makes it easier to get the project back on track.
In a project workflow fragmented between multiple companies, designers and manufacturers are often at loggerheads over various features of the requested products. Additionally, when team members need to make adjustments to the project mid-process, project leaders must coordinate between both the design department and the manufacturing company, and ensure everyone is on the same page with any changes. On the other hand, turnkey suppliers can consolidate the design and manufacturing departments into one centralized point of access. Instead of separately contacting the designers and suppliers every time a change must be made to an existing design, you’ll enjoy streamlined communication with one company and one point of contact. This also allows for quicker implementation of the necessary changes. We hire teams with years of manufacturing experience working in close collaboration with designers and equipment vendors. This results in a certain “comfort level” when it comes to implementing mid-project adjustments. In addition, all the headache of coordinating supplier schedules, managing different vendors, and sending or resending plans and prototypes is eliminated in a turnkey process. Your single supplier is fully accountable for the project and can instantly update you with an email or phone call. The ultimate result is a strong, unified design and manufacturing process.
Partnering with several different companies often results in considerable discrepancies in quality. A fragmented approach to the manufacturing process also may lead to a loss of focus for your vendors. In their mind, you are one of dozens, even hundreds of customers, and they may not have the resources or inclination to give you any preferential treatment over their other clients. In contrast, partnering with a turnkey provider like us ensures a high consistency in the level of quality. Every member of a turnkey manufacturer’s team has a vested interest in seeing your project through to a successful completion. Turnkey vendors are held to a higher degree of accountability; after all, if problems occur, there is no one else to blame. With a turnkey solution, you will receive more personalized service and a designated account contact that is exclusively focused on your project. All these factors guarantee a smoother process throughout the lifetime of the project.
A fragmented approach to a project can result in higher costs. For instance, manufacturing firms that specialize in only one phase of the project will often charge full price for their service. Invoicing methods will no doubt differ from company to company, meaning your accounting department will have to spend more man-hours organizing statements and itemizing transactions. Of course, slower lead times also incur indirect costs. Full-service turnkey manufacturers will save you money in such aspects. They frequently offer discounted rates for your level of investment as their customer. As mentioned previously, they generally deliver on quicker lead times, saving you on indirect costs. Moreover, members of your accounting department will no doubt appreciate receiving invoices that come from only one company, instead of several.
In case you want to start expanding your business on to foreign markets, we will help you here too. We will help you get answers to – How? Which products ? which market? We will provide overview of markets in different countries, their regulatory requirement, precisely what you will sell there, expected sales and how you will achieve them.
We generally start with a market entry strategy, which is a big-picture document giving the broad strokes of your direction. You can then use it to create an export marketing plan with a more comprehensive look at your target market and competition
The first round of research on the target marketto collect information:
This information should give you a good sense of whether a target market is suitable or not for your business.
We help you choose your mode of entry – how you get your products to market. Do you sell directly to the end-user, or do you work with intermediaries such as wholesalers or distributors? And even if you sell directly to a target clientele, do you require the assistance of an in-country sales agent to “open the doors” and facilitate sales.
Business Development is crucial for any company that intends to sustain its market position and market share. Business Development enables companies to expand their lines of business through new products & services, additional market segments, strategic partnerships & alliances and an extended global market reach. Business development is therefore vital for a company to maintain profitability, increase market share and discover and tap into new opportunities.
Whilst it is obvious that companies need business development to thrive, they face serious challenges in identifying, assessing and implementing the right business development strategies that lead to sustainable performance and growth.
We play a vital role in addressing these challenges and help clients by advising on the most suitable opportunities they need to follow by helping them choose from several alternatives through detailed mapping of their products & services, business plans and using our knowledge of their respective industries. Moreover we offer clients multiple options & solutions to transform potential opportunities into viable revenue streams.
For this purpose, we have developed a systematic and well-tried Business Development methodology that is based on building strategy road maps centered on customer acquisition and growth (branching into new markets or territories) as follows:
Challenges
Companies face major challenges in staying in business while maintaining their profitability and market share. The onset of fierce competition and disruptive changes in businesses and technologies forces companies to seek additional or alternative revenue streams through Business Development. Companies are further required to adapt their business models, or their product portfolio in order to defend their market position and maintain a competitive advantage over their peers. Identification of successful Business Development options remains a major challenge.
Solution to such challenges
We address the complex challenges faced by clients and utilize our market knowledge / intelligence and business expertise to identify, assess and propose successful ventures. Our in-depth business knowledge is sharpened through our continouse monitoring of various industrial segments in order to maintain our database updated covering all aspects of the business dynamics together with an up-to-date view of the business environment and market conditions. We therefore make invaluable contributions to clients by promoting their businesses, helping them gain new customers and retain existing ones.
Benefits to the clients:
Our clients can therefore benefit from a wide range of Business Development solutions including:
Advisory: This business development consulting service provides clients with tailored solutions for the business growth strategies. We rely on creativity and the unique innovative crowdsourcing business model to deliver specific results to clients in a timely, efficient, and cost-effective manner.
Partnerships: We assist clients in setting up and building strategic relationships and alliances with other relevant organizations such as multinational companies, universities, research centres and government entities. With such partnerships, clients can benefit from additional expertise, new technologies, intellectual properties to expand their products, services, market reach thus avoiding having to incur the cost for acquiring them
Liaising work:
Even after a company has new leads, new product ideas, new market ideas, concepts etc., they need approvals and licenses from state and central agencies. These work may take very long time which the company can’t afford. The company representative may be dragged from post to pillar before he / she can get even a small work done at a burecratic government offices without knowing the steps or procedure to be followed. Since we have been getting done such approvals and licenses for different companies for many years we know all the procedures and processes that need to be followed. We know whom to contact to get a particular work done. Through our right contacts and relations, we can make it easier for companies to get such government approvals.
Licensing is of enormous importance in formulating new product strategy of pharma organisations that have aggressive growth plans. Licensing is the transfer of rights to a third party (the Licensee) to use the Intellectual Property owned by the original party (the Licensor) under mutually agreed terms and conditions.
Licensing can be for manufacturing and/or marketing rights. The marketing rights could be restricted to select geographies
This Intellectual Property (IP) offered by Licensor can be one of the following:
Based on the perspective, a licensing deal can be an Out-Licensing deal or an In-Licensing deal.
Apart from various other plausible ways, Indian pharma companies have come to a realisation that in-licensing is one of the ways forward. Few pharma companies have taken full advantage of in-licensing opportunities and paved the way for their rapid growth in the competitive market. They have aligned the process with their long-term growth strategy.
Why would a pharma company be interested to go for in-licensing? This can be summarised as:
However, in-licensing does involve some risks and has a few disadvantages too. The innovator may lose control over the manufacturing and marketing of its IP. Licensing also may be less profitable as returns needs to be shared between two parties. There is even a risk that the licensee may sell a similar competitive product after the license agreement expires and efforts of Licensor go in vain. To most of the companies initial upfront fee becomes a speed breaker to kick start the process. Other risks and issues involve; speed of a partner, general uncertainties in doing business with a partner in unknown territory, language barrier, cultural differences, political risk, and currency fluctuations. Alternatives to licensing include exporting, acquisitions, establishing a wholly owned international subsidiary, franchising, and forming strategic alliances.
The approach to licensing is a well-drawn process, if followed serially, it brings predictable results. To handle this, large pharma companies have a dedicated business development (BD) department who scan the global markets for innovative and unique opportunities. In mid-sized or small or start-up companies, this activity is either carried out by marketing department or out-sourced to consulting firms who specialise in identifying in-licensing opportunities.
Most of the commercial terms involve upfront or licensing fee, however it depends on negotiations and mutual decision of involved companies. To summarise the above, Licensing is an opportunity to infuse new IP in the organisation, bring diversity in operations, boost the growth engine, supplement new revenue stream and enhance credibility of the organisation through their association with various partners. In today’s competitive scenario, BD team must structurally approach licensing as a well thought over strategy that will be imperative mainstay in placing their organisation ahead of the competition.
In case you are interested, we will connect you to national / international firms who have ready product, technology for right to produce and market in India.
Selling the rights of a developed products or potential compound to another firm for further development, production or marketing.
If you have state-of-the-art research facilities, equipped with the latest infrastructure with qualified scientists you would be able to develop new formulations and delivery systems. We will to ethusiating marketing company to whom you can out-license your developed product, technology etc.
Contract research and manufacturing services (CRAMs) is one of the fastest growing sectors in pharmaceutical industry. The pharmaceutical market uses outsourcing services from low cost providers in the form of contract research organization (CROs), contract development organization (CDOs) and contract manufacturing organizations (CMOs). Huge investments followed by low productivity in R&DS are driving companies to cut the manufacturing costs by outsourcing their research, development and manufacturing activities to low cost low cost speciallized organizations.
Clinical studies and bioequivalence studies are critical areas in Pharmaceutical industry that contribute greatly to the effective development of generic drugs and generic formulations by establishing their efficacy, safety and bio-equivalency. In India, though clinical research for innovation of new molecules is limited, companies work on discovering new indications, dosage regimen, the assessment of devices for the administration of drugs, and analyzing the safety of the developed product and determining equivalence against the reference product. The field of Clinical Research involves the development of both innovative and generic products, and the criticality of the studies conducted depends upon the type of pharmaceutical formulation, the safety data provided plus the target therapeutic indications.
We have a competent team of clinical and bio-analytical experts to guide and conduct gap analysis, as well as to assist in the compilation and submission of clinical and bioequivalence study reports to various Health Authorities (HAs).
A contract manufacturing organization (CMO) and a contract development and manufacturing organization (CDMO) are companies that serve other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing. This allows pharmaceutical companies to outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug marketing. Services offered by CMOs / CDMOs include pre-formulation, formulation development, stability studies, method development, clinical trial materials, scale-up, registration batches and commercial production. CMOs are contract manufacturers, but they can also be more than that because of the development aspect. It is required that CMO / CDMO comply with good manufacturing practice all the time as per the target country regulatory requirement. We will help you with all the above services viz. product development, scale up, regulatory batches, commercial batches etc. as per your requirement and target country requirements.
We have a competent team of clinical and Regulatory experts to guide and conduct Regulatory assessment or gap analysis, as well as to assist in the compilation and submission of dossiers to various Health Authorities (HAs).
Effective branding with strong brand values, can result in higher sales of not only one product, but of other products associated with that brand. If a customer loves and trusts the brand, he or she is more likely to try other products offered by the company. Brand building takes time. We have the in-depth knowledge of the market and are competent to provide advice on brand building strategies.
A formulator may develop an excellent product by developing right formula and process in his / her development laboratory. However it is important to develop right testing methods to establish the product actually has the right characteristics, has all the components as per the label claim, that the impurities are identified and quantified and that the shelf life and storage condition for the product are substantiated.
Analytical methods are intended to establish the identity, purity, physical characteristics of the product and potency of all the actives in the product. Methods are developed to support product testing against specifications during manufacturing and quality release operations, as well as during long-term stability studies.
Methods may also support safety and characterization studies or evaluations of product performance. The most common types of analytical procedures are:
(i) identification tests,
(ii) quantitative tests of the actives in samples of the product or other selected component(s) of the product,
(iii) quantitative tests for impurity content, and (iv) limits tests for the control of impurities.
Method development is a continuous process that progresses in parallel with the evolution of the product. As product development progresses, the analytical methods are refined and expanded, based on increased product knowledge. The methods should be robust and uncomplicated, while still meeting the appropriate regulatory guidelines.
Our team would help you get right analytical methods developed for your products and subsequently arrange get them validated complying national / international regulatory requirements. The validation of an analytical method demonstrates the scientific soundness of the measurement or characterization and is required throughout the regulatory submission process. The validation demonstrates that the analytical method measures the correct substance, in the correct amount, and in the appropriate range for the intended samples. It allows the analyst to understand the behavior of the method and to establish the performance limits of the method.
Regulatory Authorities have specific requirements and expectations when it comes to the safety and efficacy of new products and to demonstrate their bio-equivalency with the reference product
We are a leading Regulatory affairs services company and has been a pioneer in providing strategic multidisciplinary Regulatory affairs consulting services.
We provide comprehensive Regulatory affairs services across the spectrum of global product development, registration and commercialization. To help companies maximize their product’s commercial potential and succeed in different markets across globe we provide informed advice and Regulatory affairs consulting services and solutions with respect to new product and market authorizations, Health Authority submissions, post approval support, and lifecycle management.Our global Regulatory affairs services enable Pharma, Life Sciences and device companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch their products in new markets and maximize their market value. Our competent team of regulatory experts would guide and conduct regulatory assessment or gap analysis, as well as assist in the compilation and submission of dossiers to various Health Authorities (HAs).
We provide turnkey supply chain solutions and tailor-made global sourcing and procurement services in the various locations. We offer more than just standard global purchasing services. Whether you are simply looking for a new supplier or you are looking for supply chain diversification, production transfer or outsourcing to a local partner, we have the requisite expertise. We will manage your projects from inception to delivery of the goods to your chosen destination.
We support your sourcing, manufacturing and quality control needs as well as your company’s growth strategy by offering tailore made solutions.
Our team manages the entire purchasing process by taking a proactive role guaranteeing product quality and on time delivery. Below are some examples of the activities we can undertake for you:
Whether you already have identified your supplier or you have just begun thinking about a new project, we ensure that vendor performance meets your expectations. As a procurement service provider, we would represent your interests abroad. We have local presence and knowledge in several emerging markets to ensure nothing is lost in translation.
Medical Advisor is a medical expert in one or more therapeutic areas. He / she communicates with prescribing physicians, medical investigators, pharmacists and also with academic officials at the health authorities, insurance companies, scientific journals and formulary committees, and builds partnerships with them. In case you don’t have in-house medical advisory capabilities, we can support you with required expertise.
Evaluating your suppliers or facilities against your own quality, safety, or security requirements will bring your entire supply chain to a higher level of reliability. We have experts who can conduct audit on your behalf freeing up your personnel for other tasks, but also significantly reducing the travel time and cost of each audit. We can also help you develop and implement internal auditing programmes / self inspections to improve the safety, quality and efficiency of your entire operation.
Pharmaceutical companies operate in one of the most dynamic environments. Changes in regulations within India and outside India (for exporters) have increased the significance of regulatory compliance management for manufacturers. Pharma companies are compelled to alter their compliance practices to conform to changes in regulations and laws. With the FDA and other regulators broadening the scope of compliance requirements, it helps if companies have a holistic approach and make regulatory compliance part of their corporate strategy. This includes effective training, proper timely communication, periodic reviews, and support from the top management. Companies ought to be proactive in setting up stringent internal controls as part of their commitment towards quality and compliance. Regulators have to focus on aligning country-specific regulatory frameworks to global standards enabling harmonisation of standards and help companies drive efficiencies.
Besides above expectations, pharma companies need to adher to local requirements like factory act, labor laws, pollution control laws etc. Clearances from multiple government agencies require dedicated legal and administrative department.
We can get comprehensive legal compliance checked so that companies remain in compliance and don’t face complaints or legal notices from government regulatory agencies.
Companies may need professional help from outside of a business or organization to task them with solving or meeting a human resources-related need. Often they are hired to provide high-level solutions and recommendations to management teams. Small businesses simply may not have the internal HR support or expertise needed to take on significant projects such as implementing a new benefits package or creating a new employee handbook. In these situations, companies may seek out an outside professional for guidance. Besides, We provide outside perspective on a particular project or challenge. We as independent agency can focus on addressing actual problems without getting wrapped up in internal organizational politics or other issues that may make objective decision-making challenging.
One of the most important challenges faced by pharmaceutical companies, especially medium or small enterprises, is to get right talent / resources to do speciallized job in their organization. The challenge increase as you need technically competent person for this knowledge based industry. Unlike general HR recruitment agencies we can provide you pre-assessed candidates for evaluation as per your specification freeing up your personnel for other tasks, but also significantly reducing the time and cost of each interview. Selecting right person for the right job with our help will improve the quality and efficiency of your organization.
Intellectual property (IP) is a property that arises from human intelligence and a product created by humans. The term Intellectual property referring to a brand, invention, design or another kind of invention/creation, which a person or any entity has legal rights over.
General types of Intellectual Properties include Copyright, Patents, Trade Marks, Designs etc.
A patent describes an invention for which the inventor claims the exclusive rights. A registered patent protects commercial inventions, for example, a new product or process. The term of a patent is generally 20 years from the date of filing for patent rights for the creations/inventions.
We have technical expertise in assessing existing patents, guding preparation of new patent, filing applications for new patents, challenging enforcebility of patent, finding non-infringing ways out of patent etc.
