Scientific & Regulatory Services

Technical, Scientific and Regulatory (Pre and Post Marketing)

  • Technical, Scientific & Regulatory support in product development planning and designing for globalization of the products.

  • Guidance on data generation to align with the global regulatory requirements & also adapting the data for localised submission specific to each country.

  • Preparation of registration dossiers based on respective countries requirements for filing Applications to various Regulatory Agencies all over the world.

  • Guidance for data generation and preparation of response to queries received from various Regulatory Agencies.

  • Guidance and Audit for Pre and Post Approval Regulatory Compliance (including GMP / HACCP Audit).

  • Support for product grid finalisation (selection of product portfolio) based on regulatory filters.

  • Preparation and Filing of Applications for seeking approval of Novel Ingredients/Non-specified foods & Food ingredients and for Health Claims to Food Safety and Standards Authority of India (FSSAI), India.

  • Preparation and Filing of Applications for Genetically Modified or Genetically Engineered Foods to Food Safety and Standards Authority of India (FSSAI), India.

  • Regulatory support for product sale, warehousing, distribution for compliance to the respective regulations.

  • Review of advertisements, promotional materials for OTC, Cosmetics and Food & Food Supplements/Nutraceuticals for compliance to the respective regulations.

  • Assist in claim substantiation based on published Scientific literature, Clinical trial studies, Nutritional studies, in-vitro studies etc for OTC, Cosmetics and Food & Food Supplements/Nutraceuticals to get the competitive advantage.

  • Techno-Legal support in providing the Technical, Scientific & Regulatory inputs for responding to notices, court cases etc.

Strategic Planning

  • Assisting the clients in selection of product portfolio based on technical & regulatory filters and thus help in finalization of product grid.
  • Provide strategic, tactical and operational direction and support for working within regulations to expedite the launch of the products.
  • Regulatory Intelligence — Monitor the impact of changing regulations on submission strategies. Advise management on the impact of current, newly finalized or proposed regulations, guidelines and standards and make recommendations accordingly.
  • Provide regulatory input to product life cycle planning.