Experience

At Optimus, we combine strategic, technical and operational capabilities to provide high-impact, holistic service offerings that help you, our customer navigate the complex, strategic landscape of the Life Sciences business and make the right decisions.

Optimus senior practitioners have a unique blend of business, domain, technology and pharma process outsourcing expertise and include former senior executives from top Pharma, Biotechnology, Clinical Development companies, top tier consultancies, Fortune 500 enterprises, and leading outsourcing service providers.

In existence since 2008, we have worked with various regional and global customers from various Life Sciences sectors to deliver our commitments. A few examples of our engagements are given below. Write to us to know more about how we utilise our experience and innovate to provide science based optimal business solutions to your business challenges.

S.NoProfileProject Focus
1.CONSULTING :Formulation R & D CustomerProduct go-to-market strategy including in-licensing and or out-licensing. Regulatory strategy towards Market Authorisation in India.
2.CONSULTING : US & EU based Customers (Medical Device development)Global Device development regulatory strategy combining onshore, offshore outsourced model. Regulatory strategy towards Market Authorisation in India. Product development (incld. pre-clinical & clinical).
3.CONSULTING & SERVICES: Pharma ManufacturerProduct approval strategy (including pre-clinical & clinical studies). Requirement specification, Gap analysis, Gap closure, Dossier preparation. Submission management. Market authorization in India.
4.CONSULTING & SERVICES: Clinical Research Organisation (Clinical Studies catering to USFDA, EMEA, ANVISA, DCGI, MOH Israel, Japan etc.,)Provide consulting services on clinical studies, PK/PD, Biostatistics support – ongoing basis
5.CONSULTING & SERVICES: Clinical Research Organisation (catering to USFDA compliant customers)Due diligence of quality management system, functional quality procedures, gap analysis. Gap closure (three stages), risk management plan implementation, review and recompilation/rewriting of SOP’s, integrating ISO procedures and functional procedures. Hand holding during customer audit.
6.CONSULTING : Pharma / Biologics Veterinary medicines manufacturerIndia regulatory consultancy services (strategy & compliance). Regulatory strategy towards product launch. Due diligence of product launch strategies. Business intelligence / Regulatory intelligence. Project Reports on specific molecules
7.CONSULTING & SERVICES: India based Diagnostics manufacturerMarket size, Segments, SWOT, Growth, Opportunity analysis. Product selection and go-to-market strategies including in-licensing and or out-licensing. Identification of regional and global business partners. Handholding during due diligence and partnership implementation

 

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