Backed by sound educational background, professional training & hands on experience.
Extremely professional Global Regulatory affairs consultants in India
Ability to identify needs of clients and complete the assignment on time and on budget.
Build-up & retain various Indian and multinational companies.
In depth understanding of Regulatory Systems (Drugs and Cosmetic).
Good network and communication skills to initiate the business and retain the relationship and professional contacts
Deep understanding of regulations on special pharmaceutical products viz medical devices, rDNA based biotech products, orphan drugs, vaccines, combi-vaccine and blood derivative products.
Supported by strong IT expertise.
Open Source management for client update and project tracking.
Providing complementary services for clinical research organizations CRO in India and abroad.
Have Submitted more than 40 US DMFs type II, Compiled and written more than 300 DMFs in CTD format for various pharmaceutical companies.
Have compiled more than 100 ACTD & CTD Dossiers for various Pharmaceutical Companies