Regulatory Submissions
Regulatory submissions are the foundation of your development programme. Our regulatory submissions team can co-ordinate the preparation, validation, submission and maintenance of regulatory applications. Our broad functional and therapeutic area expertise enables us to provide cost-effective services to our clients according to their needs. We have substantial experience in Europe, China and the United States.
Our regulatory submission planning and services cover:
- Investigational New Drug Applications (INDs) and IND Updates
- Investigational Medicinal Product Dossier (IMPD) development
- Clinical Trial Applications (CTAs) and amendments
- Common Technical Document (CTD) compilation
- Ethics Committee applications
- On-going support for trials including Safety Reporting
- Legal Representation in Europe
Niche Science & Technology Ltd | London House | 243-253 Lower Mortlake Road Richmond-Upon-Thames | London | TW9 2LL | United Kingdom
T: +44 (0)20 8948 9588
F: +44 (0)20 8948 2525