Karen Greene

Acorn Regulatory comprises a group of experienced regulatory affairs consultants specialising in Pharmaceutical & Medical Device Regulatory Affairs and Pharmacovigilance. Our consultants have been assisting companies in all stages of growth, from start-ups to established multinationals needing assistance with global regulatory strategy. Our experience spans a broad range of therapeutic categories and thus allows us to fit in easily into existing team structures and meet your requirements with minimum downtime required for training. We are an effective solution for both your short and long-term regulatory or compliance requirements. Our services include (but not limited to): Pharmaceutical  Regulatory Applications (New MAA’s)  Expert Report Writing/ Due Diligence Reviews  Electronic Submissions  Staying Compliant (Variations/ Renewals)  Gap Analysis  Training in Regulatory Affairs or Electronic submissions Pharmacovigilance  Qualified Person for Pharmacovigilance (QPPV) Services  Electronic reporting to the Authorities & Eudravigilance  Collating and managing Signal Detection Reports  Routine literature review including local medical publications Medical Device  CE Mark Certification  European Authorised Representative Services  ISO 13485 Certification  Post-Marketing Surveillance and Device Vigilance  Medical Device Training Programmes Available We have the expertise, tools and processes to ensure that your needs are always met to the highest standards. Discover how Acorn Regulatory's expertise and approach can help you. Please call us on +353 52 6176706, email info@acornregulatory.com or visit our website at www.acornregulatory.com