Regulatory Services

Pharmaceutical sector is the most important sector as it is directly associated with the health of people and health is the single most essential thing for any human being. Why manufacturing medicines we take care utmost care of all the regulatory of all the countries and their health departments. 

We have been practicing following regulations and, thus, have expertise in regulatory services as well. When a client comes to us with the requirement of manufacturing a medicine, there is no headache of regulatory permissions as we take care of all of them for our client. 

There are multiple regulatory services that are extremely important when it comes to producing medicine. Governments all around the globe have strict norms and regulations that need to be fulfilled. 

SpecialityMedz Regulatory Services:

Registration Service:

  • DMF (CTD format) Preparation, Review, and Submission
  • Dossier Writing and Review
  • Dossier Registration
  • Notarization

Post-Approval Changes:

  • Product re-registration and
  • Renewal of site according to schedule
  • Post-approval lifecycle maintenance
  • Report compilation and publishing

Pre-Registration Service:

  • Drug Product DMF
  • Development & Preparation of documents

Content creation and document services