Regulatory

Regulatory Affairs Department is the main strength of Pharmaceutical Business :

Our Regulatory team consists of highly qualified personnel engaged in providing data required as per the Regulatory Guidelines of the different countries. Our Regulatory Team can provide a complete support to register the Products.

CTD Dossiers
ACTD Dossiers
Dossiers as per specific Guideline of all countries
Bio-Equivalence Studies with GLP certified clinical centers (BE Study)
Pharmacokinetic Studies,
Drug master Files (DMF)
Site Master File
Electronic Submission of Dossiers with all supporting documents