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.


Main regulatory

  • EMA
  • PMDA
  • 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.