Regulatory Affairs

Biodrug s.r.o. gives possibility to provide you with clear and convenient contact point, to assure the best regulatory support and fast submissions of documentation.

Our services include but are not limited to

  • Registration strategy
  • Preparation of applications and submissions (DCP, MRP and NP)
  • Regular contact with the National competent Authorities
  • Life-cycle management (variations, renewals, line extensions, annual reporting)
  • eCTD publishing
  • SPC/PIL/Labelling – preparation and translation

Contact us for more information and tell us how we can help you.

Regulatory Affairs
  • Medical device
  • Quality control
  • Quality assurance
  • Packaging
  • Raw material development
  • Research & Development
  • Production