US and International Regulatory Affairs Services
Regulatory assistance can be provided for pharmaceutical development for all types of products (small and large molecules, biologics and devices). We provide support for all phases of product development for the FDA and international regulatory agencies.
Regulatory Support Services:
- Regulatory Strategic Planning
- Liaise with Regulatory Agencies (FDA, Canadian, EU and Non EU, Aussi-Asian agencies)
- Global Sponsor Representation
- Document Preparation and Submission for Clinical Studies (INDs, IND Amendments, CTAs)
- Investigational Medicinal Products Dossier (IMPDs), NDAs and BLAs
- Electronic Submissions
- Orphan Drug Designation Applications
- Submission and Review of IRB Approvals for Clinical studies
- Preparation and Review of Investigator’s Brochure and Updates
- Safety Report Writing, Safety Monitoring and SAE Reports
- Preparation of Annual Regulatory Reports
- Regulatory Operations; Procedural Review and Audits
- Internal system audits — audits of SOPs, documents and staff training for improvement of efficiency and compliance
- Preparation of Standard Operating Procedures
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