Scientific advice & regulatory support in product development; planning and designing for globalization of the product.
Assistance in implementation of principles of the Quality by Design (QbD) approach in Pharmaceutical development and manufacturing. Risk Management, Design of Experients (DoE) and Process Analytical Technologies (PAT).
Guidance on data generation to align with the global regulatory requirements & also adaption of the data for localised submission specific to each country.
Preparation of registration dossiers (including ACTD, ICH, CTD).
Guidance for data generation and preparation of response to queries received from various regulatory agencies.
Guidance and audit for post-approval regulatory compliance (including GMP audit).
Support for product grid finalisation (selection of product portfolio / pipeline) based on regulatory filters.
Regulatory support for product sale, warehousing & distribution for compliance with respective local regulations.
Review of advertisements / promotional materials for OTC products, cosmetics, food and food supplements for compliance with respective local regulations.
Assistance in making product claims based on scientific literature / clinical trial studies / nutritional studies for OTC products, food, food supplements and cosmetics to attain competitive advantage.
Strategic Planning
Strategic, tactical, and operational direction / support for working within regulations to expedite the launch of food supplements, OTC products and generics.
Monitoring of changing regulations for impact on submission strategies.
Advice on the impact of current, newly finalized or proposed regulations, guidelines and standards.