International Regulatory

Product registrations with health authorities of the respective countries would be the key to advance in any international market. Over the years, we have gained an in-depth understanding of the regulatory framework of many countries to accelerate product registration dossiers.

At ADVIN, we have a dedicated & qualified team to handle various functions of regulatory affairs.

Our Regulatory Team can provide a complete support to register the Products in respective countries with consultation of client.

  • ACTD Dossiers

  • CTD Dossiers

  • Dossiers as per specific Guideline of all countries

  • Site Master File

  • Drug master Files (DMF)

  • Electronic Submission of Dossiers with all supporting documents

Major regulatory documents are mentioned below

  • Certificate of Pharmaceutical Product (COPP)

  • Free Sales Certificate (FSC)

  • Certificate of Origin (COO)

  • WHO-GMP Certificate

  • Certificate of Analysis (COA)

  • Certificate of pharmaceutical product (COPP)

  • Bio-Equivalence Studies

  • Pharmacokinetic Studies

  • WHO-cGMP Certificate