Domestic Regulatory Services

Services for Manufacturers


global
  • Application for new drugs including Biological, Medical Devices/Clinical Trials/Global Clinical Trials/ new claims in consultation with New Drug Advisory Committee (NDAC)/Medical Devices Advisory Committee (MDAC)
  • IND applications in consultation with IND committee
  • Subsequent new drugs
  • Clinical Trial Protocol Amendments (If consultation of NDAC is not required)
  • Fixed Dose Combination in consultation with NDAC
  • Import Registration of drugs and medical devices
  • Endorsement of Additional Product in Registration Certificate
  • Rule 37 and Neutral Code
  • NOC for Form 29 (Biological and Medical Devices)
  • CLAA in Form 28/28-D/28-E/27-C etc.
  • Import License in Form 10
  • Test License in Form 11
  • Bioavailability/ Bioequivalence (BA/BE) study
  • Extension of Shelf Life for export
  • Export of Biological Samples
  • Registration of Cosmetics
  • Registration of Ethics Committee for CT
  • Post-Approval Changes (major) in consultation with CDL, NDAC
  • Post Approval Changes (minor)
  • BA/BE Site Approval (after receipt of Joint Inspection Report)
  • Written Confirmation as per EU Directives


Services for Importers

For importers, we provide the following services


Pre-Marketing Support

  • Authorized agent/ registration holder support
    We have a valid wholesale license and support our customers by acting as an Authorized Agent or Registration Holder. We help MNCs import and register their products
  • Market Authorization
    We help our clients all the way in the process of Market Authorization
  • Import License
    We assist our clients to get the import license smoothly quickly
  • Test License
    We help prepare the complete documentation for getting the test license in Form-29, Form-30

Post-Marketing Support

  • Rule 37 Permission
    We help customers import medicines for retail sale.
  • Re-Registration
    We assist our clients update documents for filing/re-registration with appropriate documents for obtaining renewals
  • Self-life Extension
    The regulatory team at Reseapro will help you acquire shelf-life extension for your products by filing the required documents with the regulatory authorities to facilitate quick permissions.


global

Global Regulatory Services:

  • Compile, review, publish and file regulatory dossier
  • Manage the submission of dossier
  • Life cycle management and investigational filing
  • Compile and publish reports
  • Develop content and documentation
  • Pre- and post-registration services

Pre-Registration services

Regulatory and quality compliance services and export report
  • Conversion of data or document or dossier to country specific or ACT to CTD and vice versa and analysis of gap.
  • Assessing the documents and existing dossier
  • Site due diligence for Active Pharmaceutical Ingredients (API) site and Finished Product (FP) site and GMP compliance
  • Assisting and providing guidance on adequate and relevant data generation for the submission of dossier successfully to country specific regulatory Authorities.

Post- Registration services

We provide post-approval regulatory changes to ourcustomers and assist themin addressing variations (major, minor or critical). We help updateexisting documents as per the country-specific regulatory requirements. We also provide assistance in the extension of labels and shelf-life.



Consultancy services for







STATE FDAs




For more information on service offerings