Gemma Robinson, PhD 10th Dec 2013

Establishment of Acorn Regulatory Services provided Who we work with

Professional Qualifications BSc in Analytical Science, DCU in 1993 PhD, DCU in 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, veterinary and medical device companies globally.

Continued to grow steadily despite the economic downturn

Awards/Achievements: 'The 2011 Female Entrepeneur of the Year Award' by the SE County Enterprise Boards in Ireland. In 2012, was shortlisted for the Inspiration Award by TOPRA And another Acorn employee was nominated for the Horizon Award

Working Party Member to HMA involved in the development, pilot work on CESP a secure portal system for electronic submissions of pharmaceutical applications between applicants & EU Health Authorities - First Irish Company to use CESP

Customer Satisfaction

Clonmel is host to an impressive range of leading international companies; such as Abbott Vascular, Boston Scientific, Bulmers, Kentz, Merck, Sharp & Dohme, Pinewood Healthcare, Stada Production and Sepam.

Ireland is now the largest net exporter of pharmaceuticals in the world and using the broader pharmachem measure, exports were worth €55.1 billion in 2011, accounting for over 50% of all exports from the country.

Ireland’s medical technology sector has evolved into one of the leading

clusters for medical device and diagnostic products globally. Currently 250 medical technology companies in Ireland, exporting €7.2bn worth of product annually, and employing 25,000 people- the highest number of people working in the industry in any country in EU per head of population.

actively represent our customers to achieve approval first time and on time

Our team are; ◦ MSc/PhD qualified from many different sectors of Life

Sciences ◦ Experienced team with Industry or Health Authority

experience ◦ Involvement with Industry Bodies and various EU Working

Parties ◦ Flexible

Pharmaceutical Regulatory Services; Pre-licencing activities ◦ Assistance with Clinical Trial filings ◦ Preparation of new MAA’s in electronic format ◦ submission of applications to all EU health authorities ◦ Management of health authority Q’s

Post-licencing activities; ◦ Remediation work / gap analysis for legacy products ◦ Site transfers ◦ Preparation of variation applications in eCTD/NeeS format

Use of latest technology for all Regulatory submissions

Medical Device Services Build and support QMS – ISO 13485 Certification CE Mark Certification for medical device and IVD

products Post-market Surveillance and Device Vigilance EU-Authorised Representative for non-EU medical

device manufacturers Training in Device requirements

Failure is not an option In over 10 years we have never received a single rejection (100%

success rate) Flexibility Gap analysis – reduce burden following poor inspections Due diligence – divestment project quiet resource virtual office Project Management Fees Our customers have remained with us over the years (repeat

business and referrals) Continue to explore new business opportunities

5 of the top 10 global Pharmaceutical companies

Small indigenous Pharmaceutical companies Generic Pharmaceutical manufacturers

Innovative R&D organisations Large multinational Medical Device

organisations

Contact us:

+353 52 61 76706 info@acornregulatory.com www.acornregulatory.com

Ba mhaith liom buíochas a ghabháil do Jane & Orla;

Enterprise Ireland as cuireadh dom anseo anocht. Tá mé an-bhuíoch agaibh go léir as do chabhair i rith na

bliana seo.