Focus

Olon Pride: Regulatory Affairs Department

The future trends in the APIs production
 

Olon success is constantly raising thanks to a lot of brilliant people who daily give their contribution to continuous growth of our Company.

Today we’d like to celebrate one of Olon pride: the REGULATORY AFFAIRS Department

 I just wished to extend my sincere thanks to the Olon team for such excellent support over the past number of years. It is very much appreciated. A special thank you to the regulatory group (Alessandra and Cristina) who provided such excellent support in the months leading up to this submission”.

 A big THANK YOU to the entire Olon RA team who contributed to this submission. We really do appreciate Olons support with this submission””

 Glad to note the timely issuance of the most anticipated regulatory approval. We appreciate untiring support and sense of urgency from entire Olons team! 

Success!!  Formal Regulatory approval was received 5th Oct21. Thanking everyone for your ongoing support and dedication to make this happen! Well done!”

These are just few examples of the many appreciations and compliments we receive from our customers. Behind it all there is the great work and the high skills, proficiency and experience of our Regulatory Affairs Department.

 

Why are the Regulatory Affairs so important?

The regulatory affairs (RA) department is responsible for supporting the Customers in obtaining and maintaining the approval for pharmaceutical products containing the API produced by Olon Group serving as interface between the regulatory authorities (e.g. USFDA, AIFA, ANVISA, PMDA) and the Company.

The RA Dept. must keep abreast of current national and international legislation and guidelines and gives advice to the Company on how best to interpret the rules, allowing flexibility and contextualizing them to the specific market and development phase of the APIs

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What does our Regulatory Affairs team do?

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Olon Regulatory Affairs at a glance

 

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Olon Regulatory Affairs Team