Gemma Robinson PhD

Acorn Regulatory was established in 2002 by Dr Gemma Robinson.  The company has gone from strength to strength and it is now one of the largest regulatory affairs consultancy firms in Europe.

The company has a global client list and has long standing business relationships with companies in the North America, South America, Asia, the Middle East and Australia. Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects.

Professional Qualifications:

BSc in Analytical Science, Dublin City University (1993)
PhD, Dublin City University (1997) (separation of novel combinatorial libraries and biomarkers)

Initial career :

Veterinary manufacturer; Norbrook Laboratories Ltd.
Generic Pharmaceutical manufacturer: Niche Generics Ltd.
In 2002, established Acorn Regulatory – providing regulatory affairs and compliance support to pharmaceutical and medical device companies globally.
Support to other sectors; Food supplements, Cosmetics, Veterinary.

Awards/Achievements:

Received ‘The 2011 Female Entrepreneur of the Year’ by the SE County Enterprise Boards in Ireland.
2012 Nominee for the Inspiration Award by The Organisation for Professionals in Regulatory Affairs (TOPRA ).
Nominated for Digital, Science & Technology Business Woman of the Year (2016) in the Image Business Awards.
In 2014, Acorn Regulatory achieved ISO 9001: 2008 Certification from NSAI. Currently hold ISO 9001:2015 accreditation.
Working Party Member to HMA involved in the development, pilot work on CESP.
a secure portal system for electronic submission of pharmaceutical applications between applicants & EU Health Authorities.
First Irish Company to use CESP

If you would like to get in touch with Gemma, or any member of the team, please complete the form below.