Regulatory Affairs

“Building dossiers not walls”

We offer you

  • Cost effective regulatory strategies to gain competitive advantage
  • Project management
  • Establishment of Quality System in Regulatory Affairs
  • Consultation on legal basis
  • Classification of products
  • Compliance check, updating and reformatting of files
  • Due diligence
  • Managing all type of registration procedures for various products
  • Handling registration procedures in all EU Member States
  • Finding appropriate reference member state (RMS) for DCP/MRP procedures (booking of slots)
  • Preparation/compiling/publishing/validation and submission of dossiers in electronic format: e-CTD, NeeS or VNeeS
  • CE certification for medical devices
  • Life cycle management
  • Medical writing (Clinical Overview, Clinical Summary, Nonclinical Overview, Nonclinical Summary, Clinical study reports)
  • Writing Quality Overall Summaries
  • Preparation of Applications for authorisations of clinical trials and clinical investigation of medical devices
  • Preparation of product information (SmPC, PIL, labelling/mock-ups) and Translations
  • Readability Testing/Bridging report
  • Evaluation of pharmacokinetic studies (bioequivalence, etc.)