Services
International regulatory affairs and the management of drug development projects are complex activities which involve numerous people, organizations and companies. PRS participates in this arena by
- Consulting with clients on pre-clinical regulatory requirements
- Consulting with clients on clinical development plans
- Consulting with clients in scientific advice procedures
- Project managing the regulatory implementation of clinical trials
- Supporting clients in the preparation of registration dossiers
- Supporting clients in regulatory agency liaison and meetings
- Acting as regulatory affairs manager in early stage companies
Example Project Types
- Scientific advice procedures and protocol assistance procedures
- Drafting Quality & Pharmacy information (synthetics or biologics)
- Clinical Trial Authorizations (all phases)
- Orphan designations from the Committee on Orphan Medicinal Products and the European Commission
- Eligibility agreements to the centralised procedure (optional scope)
- SME Declarations on behalf of drug sponsors and consultancies
- Drafting CTD module two summaries and overviews
- Medical writing (investigator brochures/reports)
- Consulting on new legislation and emerging technologies
- Preparing Paediatric Investigation Plans
- Consulting on global regulatory strategy for new product development
PRS helps bioscience companies make strategic business decisions based on operational understanding of what it takes to succeed in clinical development and regulatory approval. This understanding is grounded in the data requirements and legal provisions.
The consulting activities and project types in this website are neither comprehensive nor exhaustive. New enquiries about drug development support or know-how which is not mentioned in the website are welcome.