Regulatory affairs & clinic

AKKA Life Sciences provides “Experts on Demand,” as well as offering a full remote service covering all Regulatory Affairs and Clinic needs, or delivered in customer facilities by consultant teams comprised of relevant experts.

Key activities provided by AKKA Life Sciences in the Pharmaceutical sector include:

  • MAA dossiers CMC part (NDA/BLA for USA, MAA for EU) and tracking.
  • Clinical dossiers CMC part (IMPD for Europe, IND for USA) and tracking.
  • Pharmaceutical establishment modification request, DMI, DMF, PSUR Reports.
  • Variations and MAA Appendices.
  • RFP (Ready For Printing).
  • Regulatory compliance: Discrepancies between MAA dossiers and industrial practice / License conformance.
  • Support in site registration/modification alongside Health Authorities.
  • Control of regulatory compliance of publicity and promotional items.
  • Writing of ATU/RTU (Temporary Use Authorizations/Recommendations).
  • Pharmacovigilance: reception and analysis.
  • Support in responding to Health Authority questions.

Key activities provided by AKKA Life Sciences in the Medical Devices sector include:

  • Support for regulatory strategy: DM classification determination, determination of applicable norms and the Notified Body (NB) for European and international market.
  • Writing/proofreading of CE marking, DMF type III, PMA and 510 k.
  • Formating and audit of dossiers according to European Regulations 2017/745 and 2017/746 (MD DIV).
  • Post-Marketing Surveillance.
  • UDI strategy.

The advantages of the competence center are:

  • Remote working complementary to Technical Assistance delivered on client site.
  • Provide scientific and technical expertise.
  • Address several types of assignment, including high volume & documentation (writing/proofreading).
  • Methodology: Locked offices, specifically secured internet connections.
  • Flexibility, reactivity: Absorption of workload peaks.
  • Shared gains of productivity & clients budget management.
  • Consultant benefits:
    • Skill-set development
    • Stimulation and co-working
    • Employee loyalty

 

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