Regulatory – Europe
Regulatory in Europe (the EU)
With an experienced partner locally positioned in Europe, Pacific-Link Consulting is able to provide a wide range of services to facilitate regulatory approval and registration of medicinal products with the European Medicines Agency (EMA). From discovery and Phase 1 IND/IMPD/CTA through all clinical stages to MAA/BLA/NDA, our EU partner will provide a successful pathway and develop a timeline to meet regulatory milestones, address critical regulatory communications and identify any potential regulatory challenges. As the processes and regulations are constantly evolving, it is imperative to have a highly skilled expert positioned in Europe. With Pacific-Link Consulting’s partner umbrella, our clients have access to this expertise without the need for additional contracts and higher costs.
Pacific-Link Consulting is able to assist with all your EU regulatory needs, including:“
- Cost-effective regulatory strategy development and consultation
- Medical and technical writing for regulatory submissions
- Preparation of eCTD applications for submission to Health Authorities
- Health Authority meeting packages – preparation and conduct
- Health Authority representation and direct negotiation services (EU Legal Representation Services)
- Annual Report preparation and filing
- Safety monitoring and reporting (SAE reporting, PSURs)
- Continuous interactions with the European Medicines Agency to streamline submissions
The above list of services is not comprehensive. Please contact us with your individual project needs so we may provide you with more information tailored to your requirements. We look forward to developing a successful regulatory plan that will meet your needs, timelines, and budget.
Other markets of expertise we serve include the United States, Canada and Japan. Pacific-Link Consulting offers comprehensive assistance to all of these key markets, from navigating unique regulatory environments to managing clinical trials (including developing clinical protocols, trial monitoring and data management) backed by over 25 years of experience.
Please contact us to learn more about what Pacific-Link Consulting can do for your project.