API regulatory support made simple
We provide the API regulatory support you need to get your products to market on time in a complex,
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.VIEW API’S
- MIT Rusia
- Taiwan FDA
- China FDA
- Health Canada
The reputation of our brand reaches far beyond the point of delivery because we share the risks and consequences of each project.