Acorn Regulatory | Pharmaceutical, Medical Device & Pharmacovigilance Regulatory Affairs Consultancy Services | Prescription, OTC, herbal & generic medicines

Pharmaceutical Regulatory Affairs

We provide an extensive range of end to end human and veterinary regulatory consultancy services with regard to pharmaceuticals, including biotechnology products, generics and cosmetics products.

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Medical Device Regulatory Affairs

Assistance can be provided for all elements of the medical device regulatory process including classification (CE marking), conformity assessment, and vigilance activities.

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Pharmacovigilance

Our drug safety team can provide post-marketing surveillance services and help meet all your pharmacovigilance obligations.

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Device Vigilance

We support medical device manufacturers with the monitoring of the safety of their products and can establish a robust post market surveillance plan proportionate to the risk class and type of your medical device.

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Training

We provide tailor-made training programmes to the Pharmaceutical industry including, but not limited to, regulatory affairs, electronic submissions and advertising.

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Personnel Outsourcing

We can provide expert personnel to support your regulatory activities in-house on a short term basis, or for permanent roles within your company.

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Acorn Regulatory is a European consultancy company providing services in pharmaceutical & medical device regulatory affairs (human & veterinary), device vigilance, pharmacovigilance, training and personnel outsourcing. We are primarily dedicated to optimising the time-to-market for your products and ensuring all your post-marketing requirements are met.

We comprise a group of experienced regulatory specialists with expertise in many different fields, including:

Human & Veterinary medicinal product applications - National/MRP/DCP/Centralised submissions
Life cycle management activities - variations, renewals, referrals
Medical Device Technical File compilation, CE Marking, Auditing
Post-marketing surveillance, ADR reporting, Expert report writing, PSURs
Training in Regulatory Affairs, eCTD/NeeS & medicinal product advertising

Acorn Regulatory has the expertise to ensure that your needs are always met to the highest standards. We are flexible and can work on your projects from our Irish-based offices or provide support on a contract basis in-house at your premises. Additionally we can offer a competitive quote, which means that we are a cost-effective solution for both your short and long-term regulatory needs.

Please call us on +353 52 6176706, email info@acornregulatory.com or send your query through our contact form, and find out how we can help.

"We have been using Acorn Regulatory’s services for more than 4 years. Acorn’s staff are extremely prepared and always helpful in finding solutions that meet our needs. The quality of their work is outstanding and they have a clear understanding of how quick market needs can change and, consequently, they are very flexible in changing priorities." Regulatory Affairs Manager - Global Pharmaceutical Company Read more testimonials

Regulatory Affairs Advisor role available

Acorn Regulatory are now recruiting