Customers

A Global Network


Global Pharma Companies

We provide CMC regulatory support to one of the world leading pharma companies.


CMOs

Confidential


SMEs

APR - Applied Pharma Research SA
IDP s.r.l.

 

Testimonials
 

 
 

I have been working with Princesse Dell’Oca for almost a couples of year now, on consulting basis, and I certainly recommend her. She helped me especially for the preparation of a pre-IND meeting with the FDA for a new dosage form of a known drug, with particular attention to the CMC part and focus on chemistry, analytical and impurities issues. She is also open to consider the whole picture of the product and the correlation among chemistry, pharmaceutical, pre-clinical and clinical issues and related implications. She speaks and understands English/American very well. Currently, Princesse is supporting me reviewing and duly updating the CMC part of an old European dossier, managing the necessary improvements in order to be in compliance with worldwide requirements for new submissions (i.e. Middle East countries, Gulf countries and China).
I assure that Princesse is a professional woman, determined person, very reliable, with good relationship, problem solving and decision making attitudes.
— Valentina Reiner, Head of Regulatory Affairs (Pharma) at APR SA and Certified Business Coach
 
 

I have known Princesse for approximately 4.5 years, while she worked in technology transfer at Helsinn. In this role, Princesse helped to ensure the successful transfer of new chemical processes and associated analytical methods into Helsinn’s active pharmaceutical ingredient production site. She was also responsible for both writing and reviewing technical CMC documents to be filed with US and European regulatory agencies. Princesse is extremely conscientious and works diligently to ensure projects are completed on time, successfully, and with the upmost quality. An exceptional project manager, Princesse promptly communicates issues and works collaboratively with team members around the globe. It is a pleasure for me to recommend Princesse.
— Ellee de Groot, Former VP at Helsinn Therapeutics