VVN innovation is the prime solution provider for Pharmaceutical, Biopharmaceutical and Medical Device Industries. We always aspire to provide an efficient, reliable, focused and value added supporting Regulatory Affairs, Formulation packaging and development, Clinical batch manufacturing, Biotechnology, Customized impurity synthesis and API intermediates.

About Us

VVN Innovation facilitates a healthier world by supporting healthcare community through scientific expertise, process excellence and regulatory services to deliver innovative medicines that help to treat a wide range of ailments.

We have strong scientific track record as preferred partner to healthcare provide across the globe, supporting them in conceptualizing from innovative ideas to clinical studies and to full commercialization.Our team consists of highly skilled, experienced experts and provide the services in different area.

Our services

  • Regulatory Services
  • Formulation and Packaging Development
  • Clinical Manufacturing
  • Pharmacovigilance
  • Medical device

Regulatory Services

VVN innovation provides a creative, flexible, dedicated and quality centric regulatory affairs support to Pharmaceutical and Biopharmaceutical companies based across the globe on timely registration of their products globally. VVN keeps a track of the ever- changing legislation in all the regions and also advise on the legal and scientific requirements for the registration of products.

VVN provides end to end solution for preparation and filing of registration dossiers for

  • Investigational New Drug (IND)/Clinical Trial Applications (CTA)

    • Review and writing of Investigation brochure (IB), clinical trial Protocoland clinical trial study reports
    • Maintenance of INDs/CTAs as per country specific regulations includes Annual Report/DSUR, Clinical Trial Protocol Amendments, Information Amendments, Meeting Request,Special Protocol Assessments etc.
    • Preparation and review of Quality Summaries, Non-clinical &Clinical summaries and CMC sections.
    • Complete filing solution for Fast-track, Breakthrough, PRIME Scheme, Orphan drug Designation, iPSP Application for expedites approvals of drugs and biologics.
    • Global Regulatory Strategy and implantation.
    • Non-clinical and Clinical writing through literature search/published studies/publications from different sources.
  • New Drug Application (NDA)/Marketing Authorization application (MAA) and Biological License Application (BLA)
  • Planning and conducting of Bioavailability (BA) and Bioequivalence (BE)
  • ANDA preparation, review and submission
  • Drug Master File (DMF) or Active Substance Master File (ASMF) as per ICH eCTD/ASEAN CTD/Country specific guidelines

Formulation and Packaging Development

VVN innovation has expertise in developing of Solid dosage form (Tablets, capsule), liquid orals (suspension, syrups, drops), Suppositories, Parenteral dosage forms, Inhalation powders, creams, gels, ointments as well as provides trouble shooting solutions in all formulation dosage forms.

Based on client request/needs, can design and develop robust formulations at a fast pace.

Provide Regulatory input to R&D team in terms of product development including for products where FDA may not have requirement published.

End to end service from development to manufacturing site transfer

Packaging Design & Development

All veterinary formulation dosage forms development

Clinical Manufacturing

VVN has expertise in clinical formulation development and clinical batch manufacturing. Our focus is to reduce risk, time and cost for clinical formulation with regulatory compliance for human studies.

Develop the formulation for first in human, all GMP manufacturing support and phase 1/2/3 clinical trial management and double-blind clinical trials.


VVN has a team of scientific and medical expert with broad experience in Pharmacovigilance and provide the following PV services.

  • Guidance and support in development, drafting and review of Standard operating Procedures (SOPs)/ working instruction for pharmacovigilance activities.
  • Authoring of Safety data exchange agreement and preparation of Risk Management plan
  • Signal Management and Risk Minimisation activities
  • Development and Maintenance of company core datasheet (CCDS) and labelling
  • ICSR management, Aggregate Safety Reports i.e. PSUR,PADER
  • PV training to the staff and Audit support

Medical Device

VVN offers a complete range of Regulatory services to provide you with the solutions to successfully introduce your medical devices to the US, European and emerging markets and ensure continuity. VVN has expertise for all aspects of the medical device regulatory approval and post changes.

Our team of experts will guide you on:

  • ISO 13485 and FDA compliance evaluations, product safety
  • Developing FDA regulatory compliance strategies across the full lifecycle of product development, including preliminary activities, pre- market, launch, preparation, and post-market.
  • Technical writing for FDA submissions including 510(k), PMA, Pre- Submission, IDE, HUD, and Master Files.
  • Creating and reviewing validation documentation for a wide range of medical device manufacturers to meet both FDA and ISO guidelines
  • Regulatory due diligence & gap assessment
  • QMS implementation and/or improvement
  • Post market surveillance assistance
  • Regulatory advice and updates and MDR / IVDR Gap Analysis

Customized Impurity Synthesis and API intermediates

Our strong footprint in the synthesis of impurities including those present in APIs, degradation impurities, metabolites as well as internal reference standards. We offer high quality of API Impurities, EP, USP, BP impurity standards, Herbal API Impurities, Impurities of Drug Standards, Active Pharmaceutical Ingredient at competitive price.

Our team of skilled and experienced scientists has an unprecedented expertise in the synthesis of intermediates and KRMs/ KSMs . We provide our clients with customized intermediates as per their needs. The same can be scaled up from milligrams to kilograms as well.

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