Regulatory support
API regulatory support made simple
We provide the API regulatory support you need to get your products to market on time in a complex,
interconnected world.
Pharmaceutical companies must meet the quality and safety standards established
by the country where
their product will be marketed, regardless of where it is manufactured.
The demanding quality standards of every Lebsa product guarantee compliance with the strictest regulations in the world.
Regulatory and documentation
Our specialist regulatory and documentation team have deep knowledge of the commercialization process. Their extensive experience gives you the agility, advice and understanding you need to navigate the registration of API’s with the main regulatory agencies
All standard Lebsa products have EU DMF/ ASMF (Active Substance Master File) in CTD format (Common Technical Document) and/or CEP, which guarantee a robust manufacturing process, data integrity and traceability, and we provide regulatory support to pharmaceutical companies.
VIEW API’SMain regulatory
agencies:
- EMA
- PMDA
- ANVISA
- TGA
- MIT Rusia
- Taiwan FDA
- China NMPA
- Health Canada
The reputation of our brand reaches far beyond the point of delivery because we share the risks and consequences of each project.