Post-MA lifecycle management

Atessia guides you through the lifecycle management of your MAs.

  • Variations classification – Grouping – Worksharing
  • Drafting administrative variations and transfer/national modifications relating to holder/exploitant
  • Drafting pharmaceutical and medical variations
  • Update of the product information (SmPC, labeling, PIL)
  • Update of MA dossier Module 3
  • Answering the authorities’ questions on ongoing procedures
  • Drafting renewal dossiers
  • Reformatting your files in eCTD format (baseline)
  • Reformatting national or European files for export
  • Preparation of “duplicate”
  • eCTD publishing and submitting on European platforms (CESP and PSUR Repository)
  • Regulatory point of contact
  • Identification of needs, management and deployment of the activity
  • Industrial transfers
  • Coordinating your service providers (PV, distribution, advertising)
  • Organizational strategy for team structuring
  • Interim management: possibility of providing an Acting Head Pharmacist
  • Auditing MA files (focus on the pharmaceutical aspect), with risk analysis and associated action plans
  • Due diligence and preparing gap analysis-type reports
  • Critical analysis of documentation from subcontractors (validation of manufacturing processes and analytical methods, stability protocols)
  • Critical review of PQR and associated CAPA
  • Risk analysis (trends, recurrences and OOS)
  • Recommendations and risk minimization (e.g. nitrosamines)
  • Update of Module 3 sections Active(s) Substance(s) parts (CEP, ASMF) and finished product
  • Strategy for implementing early access: eligibility, positioning, reverse scheduling
  • Support in the preparation of early access authorisation applications
  • Submission of the early access authorisation to the French authorities
  • Support for the EAA-MA transition
  • Management of the EAA via our specialised exploitant partners
  • Drafting of the patient follow-up protocol (PUT-RD and PUT-SP) and annexes (prescription form, etc.)
  • Assistance in responding to ANSM regarding new compassionate uses (AAC) or the development of a compassionate prescribing framework (CPC)
  • Support with incorporating early access and compassionate use into the company’s quality management system (QMS)
  • Regulatory contact point for French authorities

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.


To better manage your projects from A to Z, Atessia offers LIFECYCLE & COMPLIANCE subscription packages. Technical support can meet your team’s needs throughout the year.