The Food and Pharma Regulatory Consultants.

Regulatory Wisdom

We provide high quality solutions
for your food and pharma products.

We are a professional food and pharma regulatory consultancy firm that ensures success for your product every time.

Strategic Planning

Assisting the clients in selection of product portfolio/product pipeline based on technical/regulatory filters and thus helps in finalization of product grid.
Provide strategic, tactical and operational direction and support for working within regulations to expedite the launch of food supplements, OTC and generics.
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 lifecycle planning.

Markets

Less regulated markets e.g. India, Asia Pacific, CIS, Middle- East, Africa etc.
Regulated markets e.g. U.S.A, Europe, Canada, Australia etc.

Development and Data Generation

Assisting the clients for development of new products and data generation in line with country specific registration guidelines.
Assisting the clients to upgrade the existing products by additional data generation to the requirements of new countries.

Registration

Preparation of Registration dossiers for submission to various Regulatory Agencies all over the world (including CTD format).
Assistance in Response to queries for submission to the Regulatory Agencies.

Post-Approval

Regulatory Assistance in Post-Approval compliance. Assisting in product sale, distribution and warehousing for Prescription products, OTC (Ayurvedic/Herbal & chemical) and Food Supplements from Regulatory perspective.
Assisting the clients for product claims (OTC and Food Supplements) backed with scientific literature so as to get competitive advantage.
Assisting the clients on advertising and marketing promotional material from Regulatory perspective.