Regulatory

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.

ACTD Dossiers

CTD 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

We can also provide you

Certificate of Pharmaceutical Product (as per WHO), Free Sale Certificates, Certificate of Origin, Halal Certificates, Kosher Certificates, TSE-BSE Certificates.