Regulatory Affairs

Compliance Guarantee – Premium Pharmaceutical Regulatory Services

Ensure full compliance with all regional regulations through our reliable drug registration services. We bring decades of experience and over XXX registered products.

If you are looking for a professional and knowledgeable partner for the registration of medicines, medical devices, dietary supplements, biocides, and other products, place your trust in us.

We offer:

  • Professionalism and Experience – Extensive experience in every step of regulatory processes and the successful registration of numerous brands in local markets, making us a trusted partner for all your needs.
  • Know-how – Our regulatory experts, with broad experience in all regulatory procedures, communicate efficiently with authorities in every country where we operate.
  • Compliance-focused Approach – We ensure your products fully meet all legislative requirements.

Our range of services includes:

  • Preparation of registration dossiers in CTD format and other appropriate formats
  • Translation and submission of documentation to relevant authorities
  • Proposal of external and internal packaging designs
  • Preparation of product summaries and product information
  • Monitoring the registration process until the marketing authorization is obtained
  • Amendments and updates to registration documents, registration renewals
  • Pharmacovigilance and vigilance activities

And that’s not all – we additionally guarantee:

  • High standards in processes and service quality
  • Validation of compliance with regulatory requirements in regional markets
  • Fast and secure delivery to end users

Contact us for detailed information!