Parolin Pharmaceutical

Regulatory

Our Regulatory team comprises highly skilled professionals dedicated to furnishing the necessary data in compliance with the Regulatory Guidelines of various countries. They are capable of delivering comprehensive support for product registration.

• 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 (following WHO standards), Free Sale Certificates, Certificate of Origin, Halal Certificates, Kosher Certificates, and TSE-BSE Certificates.