We provide a wide range of regulatory affairs services to companies in the pharmaceutical and medical device sectors. Here, we have listed just some of the services that we offer and the sectors that we cover. If you would like more information about how Acorn Regulatory can help you to navigate the maze of regulatory issues please contact us. Also, if the service that you are seeking is not listed below we would encourage you to get in touch. As one of the longest established companies in the sector and one of Europe’s largest regulatory affairs consulting firms we have worked on a wide variety of projects for companies all over the world and we may be able to help.
Here are the sectors that we cover:
Regulatory Affairs Services for the Pharmaceutical Sector
We take the hard work out of regulatory submissions by taking your raw data and transforming it into the appropriate file types that are required by the Competent Authorities. From R&D to Manufacturing through to Distribution, Sales & Marketing personnel, we can liaise with your team to collate the relevant data and create your medicinal product application. Read more here.
We offer a complete and comprehensive pharmacovigilance service to assist you in meeting your legal obligations as Marketing Authorisation Holder (MAH). We are here to help you with some or all of your pharmacovigilance needs. Read more about our PV services here.
Regulatory Affairs Services for the Medical Devices Sector
Obtaining and maintaining CE Mark Certification can be a complex process. Acorn Regulatory will help you at every stage by determining the correct regulatory pathway for your product; including Notified Body selection and appropriate device classification. We have a wide range of experience in different product technologies and can advise you on the pre-clinical and clinical data needed for CE Mark Certification. Our team of medical device experts will prepare your Technical File and obtain CE Mark Certification for your product. Read more about our medical device sector here.
Here is just a sample of the services that we offer:
Wholesale Distribution Authorisation Services
Every day we work with organisations who are seeking to obtain a Wholesale Distribution Authorisation (WDA). A WDA is required in order to conduct wholesale activities of medicinal products. Our team will provide the required support, knowledge, experience and tools to ensure your organisation secures a WDA from the Health Products Regulatory Authority (HPRA). Read more about our WDA services here.
Electronic Submission Services
We can help you to prepare your submissions in eCTD and submit them to the relevant agencies on your behalf. Acorn Regulatory manages the electronic submission process for a large number of clients. Read more about our eCTD services here.
Advertising Compliance Review Services
We work with a multitude of clients to ensure advertising compliance on a daily basis. Advertising of medicinal products in Ireland is governed by a statutory instrument (S.I.) 541/2007, which transposes into Irish law Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC). The team at Acorn Regulatory ensures that client companies are compliant with all relevant legislation. Read more about our advertising team, and the work that they do, here.
EU Authorised Representative Services
If your company is a medical device manufacturer that exports its products to Europe you are required to establish an Authorised Representative in the European Union. The EU Authorised Representative is the primary contact for the national Competent Authorities and the EU Commission. We have significant experience of working on behalf of clients all over the world as their EU Authorised Representative. Read more about our EU AR work here.
Clinical Trials Services
We offer a wide range of services to help you with getting your clinical trial off the ground in Europe. With our partners across Europe, we have extensive experience in navigating this complex landscape with its many country-specific and local requirements. Clinical trial application requirements vary widely across Europe with a poor level of harmonisation. At both a competent authority and ethics committee level, no two countries are the same. Our team of experts can help you every step of the way. Read more about our CT services here.
Resourcing of Staff & Outsourcing Services
Rather than applying a ‘one size fits all’ approach, at Acorn Regulatory we endeavour to align our resources and our response around your specific objectives. We recruit for many of our client companies on a regular basis. We also work as their outsourced regulatory affairs department. Read more about these services here.
If you would like to talk to us or receive more information then get in touch. Complete your details below and we will get back to you.