Regulatory
We provide the following regulatory affair services:
- IMPD and IND submissions
- Clinical trial approval/exemption applications or notifications in Europe and USA
- IND amendments and annual reports
- NDA's for US submission and MAA dossiers and Expert Reports for EU submission
- Abridged MAAs
- Chemistry, Manufacturing and Controls documentation
- Nonclinical Toxicology, Pharmacology, ADME documentation and summaries
- Clinical documentation and summaries
- Preparation of Summaries of Product Characteristics (SmPCs) and package inserts
- Mutual Recognition submissions
- EU Centralised Application
- Submission and follow-up of applications with the regulatory authorities
- DMF preparation
- Standard Operating Procedures, Batch Records, Tech Transfer Documentation
- Planning, rehearsing and attending Regulatory Authorities, EMEA, CPMP etc, meetings
- Advice on product classification and regulatory strategy for borderline products, including herbal medicines
