Technical and Regulatory Documentation
At **AVISAN**, we consider **technical and regulatory documentation** to be the **backbone of compliance** with **GMP requirements** and the expectations of **national and international regulatory authorities**. We provide **professional services in the development, review, and structuring of documentation**, supporting the establishment of a **cohesive, well‑organized, and fully traceable system** within your organization.
- Preparation of **Production, Quality Control (QC), and QC Release Documentation**
- Development of **Master Batch Records (MBR)** and **Product Dossiers**
- Product Registration with the **Food and Drug Administration**, and Support for **Export and International Market Entry**
Development of **Technical and Regulatory Documentation**
Development of **Technical and Regulatory Documentation** in Compliance with **WHO, EMA, and FDA Requirements**
Preparation of **Quality System Documentation**
Preparation of **Quality System Documentation** *(SOPs, Forms, Procedures, and Work Instructions)*
**Design and Drafting**
Design and Drafting of **Product Registration Dossiers**, Including **CTD Modules**
Review and Optimization of Documentation Structure
Review and Optimization of Documentation Structure** to Ensure **Alignment with International Regulatory Requirements**
Personnel training
Training personnel on the principles of proper documentation and the documentation control cycle
Our experience in industrial projects and product registration serves as a guarantee for delivering reliable, high‑quality documentation that is fully accepted by both domestic and international inspection and regulatory authorities.
