Post-MA lifecycle management
Atessia guides you through the lifecycle management of your MAs.
Maintaining your mature MAs files
- 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)
Project management
- 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
CMC - compliance
- 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
Early access and compassionate use in France
- 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
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.