Outstanding regulatory affairs solutions

Entrapharm regulatory affairs team helps you increase your chances of regulatory approval in the markets of Central and South Eastern Europe:

  • Submission of marketing authorization application dossiers for medicines
  • Registration of food supplements, food for special medical purposes, medical devices
  • Monitoring of the authorization process, communication with the health authorities
  • Preparation of product information in accordance with national legislation (SmPC, PIL, labelling)
  • Mock-up preparation
  • Regulatory maintenance
  • Regulatory advice
  • Regulatory support with new development products

As your pharmacovigilance partner, Entrapharm helps you establish an efficient pharmacovigilance system to monitor safety of medicines in the market and to assure the safety of your patients. Entrapharm provides you a partnership in post-marketing pharmacovigilance with the following activities:

  • Education of employees
  • Managing ADR procedures (initial, follow up)
  • Literature searches
  • RMP and education material applications management
  • Archiving
  • SOPs management
  • etc. 

Entrapharm offers you cost-effective services that allows you to find the right balance of regulatory affairs, safety monitoring and product management for your products so you can take advantage of all economic opportunities and at the same time meet all regulatory requirements and post-authorization commitments.