DUE Pharm

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REGULATORY AFFAIRS

DUE Pharm is skilled and experienced in delivery of the full range of regulatory services, which is confirmed by our outstanding rate of successful regulatory applications.

​Over the years, we have developed an efficient and good standing relationship with the Health Authorities, especially in the EU  and EAEU countries.

  • Dossier assessment and analysis preparation before submission.
  • Assessment of regional requirements, strategy report preparation.
  • Full dossier preparation / compilation 
  • Medical writing (Clinical, non clinical, quality, safety sections of the dossier).
  • Full life cycle management for the product(s) in various procedures (New submissions, variations, renewals).
  • eCTD compliant publishing services for initial submissions/renewals/variations.
  • Marketing Authorization Holder Service including a full Pharmacovigilance system.
  • Technical File assessment and analysis preparation before submission.
  • Guidance on medical device classification.
  • Technical File Preparation/ compilation.
  • Medical writing.
  • Full life cycle management for the product(s) to obtain the CE Marking and certification.
  • Product(s) assessment before submission.
  • Document preparation (according to the national requirements).
  • Full life cycle management of the product(s) to obtain the registration.
  • Product(s) assessment before submission.
  • Cosmetics product information file preparation.
  • Full life cycle management of the product(s) to obtain the registration.

Analysis

Dossier assessment and analysis 
preparation before submission

Strategy

Assessment of regional requirements, 
strategy report preparation

Compilation

Full dossier 
preparation / compilation

Writing

Medical writing of clinical, 
non clinical, quality, safety sections 
of the dossier

Publishing

eCTD compliant publishing services 
for initial submissions/
renewals/variations

Provision

Marketing Authorization Holder 
Service including a full 
Pharmacovigilance system

Management

Full life cycle management 
for the product(s) in various procedures 
(New submissions, variations, renewals)