I will prepare ctd modules and cmc regulatory documents
À propos de ce service
Are you looking for reliable support in preparing regulatory documents for pharmaceutical products or medical devices?
Im a pharmacist with regulatory affairs experience, offering professional assistance in preparing, reviewing, and formatting regulatory documents aligned with international guidelines.
I can support you with:
- CTD / eCTD document preparation and formatting
- IND and NDA documentation support
- SOPs, policies, and quality documents (GMP)
- Pharmacovigilance documents (PSURs and safety reports)
- Regulatory document review and compliance checks
- Labeling and packaging compliance review
- Bilingual support (English and French)
Ideal for
- Pharmaceutical companies
- Medical device companies
- Startups and regulatory professionals
- Startups and small to medium-sized companies
Please contact me before placing an order to discuss your requirements.
For larger projects (full CTD modules, specifically module 03 or submissions), custom offers are available.
Note: I provide support in document preparation and review only. I do not submit documents to regulatory authorities.
Type de document:
Documentation
•
Rapports
Secteur:
Médical & Biotech
Langue:
Anglais
•
Français
Préférence du type de livraison
Veuillez informer le freelance de toute préférence ou préoccupation concernant l'utilisation d'outils d'IA dans la réalisation et/ou la livraison de votre commande.
FAQ
What types of regulatory documents can you help prepare?
I specialize in crafting a variety of regulatory documents, including high-quality submissions, product registrations, and quality management system documents. Whether you need assistance with specific documentation or a comprehensive regulatory package, I've got you covered.
What languages can you use ?
I can write and speak both French and English perfectly!
Do you currently work in regulatory filed ?
Yes , I work a full-time job in regulatory affairs, quality, and compliance.

