Our Services

Regulatory strategy for new product introduction
Expert guidance throughout the regulatory submission process
Technical documents (Product Dossier) preparation for product (drugs, Food, Cosmetic, Medical devices) registration in various countries all over the world.
We can act as your authorized Indian agent and representative, and will get sorted all the licensing, filings and approvals needs for easy penetration in to Indian market.
eCTD & CTD dossier preparation
DMF compilation in CTD Format / Country Specific format
Life-cycle management of Drug master File (DMF)
Post-market surveillance compliance
Training and education
Preparation of FDA 483 and warning letter responses
Warning Letter and Consent Decree Remediation
Preparing the management for FDA meetings.

Subscribe