Why Us:
* 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
