REGULATORY AFFAIRS UNIT provides regulatory expertise and full-service regulatory consulting in all of our countries of operations in Europe (EU and non EU). With support of our locally based colleagues, we constantly observe the regulatory arena in Europe and are fully aware of any new and / or modified requirement. Our presence during the entire lifecycle of a clinical trial enables us to achieve the regulatory goals within the timelines required for Clients’ successful drug development process.
In order to be successful in regulatory arena in Europe, Accelsiors Regulatory Affairs Unit has a country-by-country approach, meaning that regulatory requirements in each of our countries of operations are considered to be specific, despite of EU Directive introduction. Hence, regulatory strategy for every project is specifically tailored not only for the particular project, but for the particular country. Our staff has contact with national regulatory authorities in our countries of operations in Europe, as well as with European Medicines Agency.
After performing the regulatory risk-benefit-assessment, our clients are advised on the most appropriate regulatory strategy for their project. Our mission is to guide clients through regulatory aspect of the project making the pathway from which their drug development process will benefit the most. In general, that starts with CTAs, includes reporting (e.g. progress reports), notification process for various possible amendments (e.g. Protocol, patient documents, IMPD, IB), goes over notification of end of trial and ends with notification of clinical trial report. In addition to general regulatory aspects, this pathway includes country specific regulatory requirements as well.
By combining our experience, expertise and dedication to each project, we work as a team in close collaboration with other Accelsiors operational units as well as with Clients’ departments. The multilingual and relocated working environment enables Accelsiors Regulatory Affairs Unit to act and perform required regulatory activities in the most efficient manner, minimizing the risk of potential delays and ensuring each of Clients’ project milestones are met.
One of the first contacts each of our new Clients will establish at Accelsiors is with Regulatory Affairs Unit representatives, which is then maintained until the very end of the project related activities. Therefore, Client satisfaction is our main goal, which is achieved through exceptional collaboration and our dedication to make use of our extensive expertise in order to launch and run your project in the desired pace and direction.
Our Regulatory Services include:
- Development of Regulatory Management Plan
- Preparation / Coordination of Pediatric Investigation Plan (PIP)
- Notification on Clinical Trial Application Requirements
- Procurement of local patients’ insurance
- Development of regulatory strategy
- Review of documents required for CTAs
- Preparation and management of Clinical Trial Applications (CTAs) to Regulatory Authorities and Ethics Committees (Central and Local)
- Guidance for responding to deficiency letters / rejection letters / appeals
- Compiling / Review of Investigational Medicinal Product Dossier (IMPD)
- Development / Review of Label text
- Follow-up: notification of amendments, early terminations, temporary halt of a clinical trial, end of clinical trial, summary of clinical trial report
- Preparation and management of progress reports
