Our Services for the Pharmaceutical Industry
We provide full regulatory affairs services for your medicinal product MAA.
In addition to essential expertise on regulatory affairs and quality in the allopathic medicinal products area, ASPE Conseil offers the special advantage of extensive experience in the area of traditional use medicinal products and well-established use medicinal products, with specific expertise on homeopathic and phytotherapy products.
We also have a proven track record of managing projects involving biotechnological health products.
Through partnerships forged with other service companies, we are able to provide an integrated package of services.
- Full or tailored management of your projects from product development to the supply of a ready-to-use registration file tailored to regulatory requirements.
Clinical Trial Authorization
- Reviewing or drafting Investigational Medicinal Product Dossiers (IMPD).
- Reviewing or drafting Investigators’ Brochures (IBs).
- Guidance with submitting clinical trial authorization applications to the relevant authorities
- Drafting expert reports: quality (Module 2.3. – QOS), non-clinical overview (Module 2.4) and clinical overview (Module 2.5).
Readability User Testing
- Full management of the RUT.
- Preparation of the final report in version ready for submission in compliance with CTD module 1.3.4.
Risk Management Plan
- Drafting of risk management plans.
- Submissions to the relevant authorities in connection with MA registration applications.
- Management of MA registration applications.
- Drafting, formatting or updating applications (Modules 1 to 5) in CTD or eCTD format based on any type of procedure (national, decentralized, mutual recognition, centralized).
- Submissions to the relevant authorities and procedure tracking.
- Drafting responses to authorities inquiries.
- Drafting the CEP, ASMF and DMF.
- Management of MA variations.
- Identification of the variation classification.
- Drafting variation dossiers.
- Submitting and tracking dossiers with the relevant authorities.
Audit & Training
- Performing internal and supplier audits.
- Designing and delivering tailored, practical and relevant training to raise your employees’ awareness or enable them to independently implement various regulations, good practice (GLP, GCP, GMP and GDP), and pharmaceutical sector standards.
Assistance in dealings with the relevant authorities
- Representing pharmaceutical companies in dealings with the relevant national or European authorities.
- Discussing issues as a direct representative.
- Attendance of scientific meetings.