Regulatory Affairs Department is the main strength of Pharmaceutical Business:
Our Regulatory team consists of highly qualified personnel engaged in providing quality services in regulatory affairs documentation 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.