Our local experts knows the difference between regulations and actual real life practice. Often, this is important for achieving your goals. 

Documentation compilation and regulatory procedures

  • Dossier Preparation: Module 2.3 and 3

  • Dossier Preparation: Drug Master Files

  • Preclinical and clinical summaries and overviews

  • Pre-submission meetings

  • Submission of marketing authorisation applications

  • Follow-up including answering of authorities’ concerns

  • Translation services

  • Variations, Renewals

  • Marketing Authorisation holdership

  • Centralised Procedure (CP)

  • Mutual Recognition Procedure (MRP)

  • Decentralised Procedure (DCP)

  • National procedures (EU, CH, USA, Canada, SEE, Russia, Ukraine, Belarus, Latin America, East Asia, others)

  • SME status application at EMA

  • Paediatric Investigational Plan (PIP)

  • Orphan Drug Designation (ODD)

  • Rx to OTC switch

Currently we work with 40+ life science companies at 80+ projects, across 20+ countries.

Contact us for larger international projects or visit MicroJobs site for small jobs and webinars.

Work with us