Regulatory Expertise

Regulatory Expertise

Regulatory Expertise

Olon Regulatory Affairs Department is a major asset and it has seen significant development and diversification of its expertise in terms of regulatory frameworks and requirements of different geographic areas, including the most complex and demanding ones. We hold in-depth knowledge of the worldwide regulatory processes, including Countries as China, Brazil and Japan ─ expertise gained from decades of consolidated, hands-on experience.

Our drivers are strategic consultancy, transparency, and continuous feedback to our customers for both generic and CDMO projects. Olon RA team comprises 35 highly qualified professionals located in Europe and Asia.

With as many as successfully submitted worldwide in support of our customers’ marketing authorizations and clinical trials, with its diverse, in-depth knowledge of international regulatory frameworks, Olon regulatory affairs service represents an excellence in the API industry.

Internal excellence serving the customers:

  • Regulatory process centralized at the HQ
  • Unique point of contact supporting the Partner along the entire process
  • Strong internal expertise, high skills and deep know-how
  • We submit DMF inside ICH and outside ICH
  • We manage them globally, covering all geographic areas, including countries with highest demanding regulatory system as Latin America, Far East, China, Russia, Japan, WHO, Africa Regulatory Bodies, Australia