Post-MA lifecycle management

Atessia guides you through the lifecycle management of your MAs.

  • Drafting and submitting administrative, pharmaceutical and medical variations (updated product information): Classifying of variations – Grouping – Worksharing
  • Drafting and submitting renewal applications
  • Drafting periodic safety update reports (PSUR/PBRER)
  • Answering the authorities’ questions on ongoing proceedings
  • Reformatting your files in eCTD format (baseline)
  • Reformatting national or European files for export files
  • Industrial transfer projects
  • Coordinating your suppliers
  • Organizational strategy for team structuring
  • Interim management: possibility of providing an Acting Head Pharmacist
  • Auditing MA files with a focus on the pharmaceutical aspect
  • Due diligence and preparing gap analysis type reports with risk analysis and associated action plans
  • Critical analysis of documentation from subcontractors (protocols and validation reports, etc.)
  • Updating Module 3 of the MA file
  • Support responding to an RTU or compassionate access request from the authorities
  • Implementing the patient follow-up protocol and appendices (prescription form, etc.)
  • Support with incorporating the RTU into the company’s quality management system (QMS)
  • Regulatory contact point

Further information

Download the document "Chemistry, Manufacturing, and Controls (CMC)"
Download the document "Innovation from clinical trials to compassionate use"

A dedicated team of experienced and specialized CMC consultants in the fields of chemistry, formulation and analytics accompanied by a network of recognized pharmaceutical experts.