Post-MA lifecycle management
Atessia guides you through the lifecycle management of your MAs.
Maintaining MAs files
- 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
Project management
- Industrial transfer projects
- Coordinating your suppliers
- Organizational strategy for team structuring
- Interim management: possibility of providing an Acting Head Pharmacist
CMC - compliance
- 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
Temporary recommendations for use (RTU) or compassionate access
- 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
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.