Services - Regulatory
After Dr. Wagner worked for one year as the internal auditor for a medical device company, the client filled out our Client Quality Assessment: “Most of the consultant services used in the past were very specific in the scope of their activities. SCI provided general guidance through the auditing activities that provided more of a global perspective of the quality systems activities. Overall, the comments, suggestions and insight provided by SCI gave us a positive direction for improving our quality systems.”
We provide the following domestic and international regulatory affair services:
- Develop Regulatory strategies for domestic or global markets
- IMPD and IND submissions
- Clinical trial approval/exemption applications or notifications in Europe and USA
- IND amendments and annual reports
- Orphan Drug Designation Requests for Rare Diseases
- 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 Applications
- 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 and/or nutraceuticals
