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- New Chemical Entities
- Generic Drugs
- OTC Products
- Medical Devices
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Our expertise in global drug development uniquely qualifies us as the
provider of a variety of medical and regulatory services.
Medical and Clinical Consulting
- Consulting on the Complete Product Development Program (all phases)
- Reviewing and Assessing Clinical Protocols
- Reviewing Safety and Efficacy Related Issues During Product Development
- Adjudicating Clinical Data
Worldwide Drug Safety and Pharmacovigilance Services
- Clinical Trial Safety Services
- Post-Marketing Surveillance Services
- Pharmacovigilance Consulting Services
- EudraVigilance Reporting
Regulatory Support of New Chemical Entities
- Global Regulatory Strategies
- Regulatory Support of All Phases of Clinical Development (IND/CTA,
import permits, export waivers, GCP auditing, etc.)
- CMC (Chemistry, Manufacturing, Control)
- Medical Writing
- Labeling
- Translations of Technical Documents
- Coordination of Regulatory Certificates
In-licensing of Products for Marketing in the Emerging
Markets
- Assessment of Local Medical Need
- Assessment of the Local Business Opportunity
- Assessment of the Appropriateness of the Existing Documentation for
an Approval in the Target Countries
- Potential in-licensing of the Product
- Serve as the Local Marketing Authorization Holder
- Sales, Marketing, and Distribution Performed by a Local Distributor
- Postmarketing Regulatory Maintenance
Regulatory Maintenance of Marketed Products
- Life Cycle Management of Recently Marketed Products
- Regulatory Maintenance of Older Products
- CMC (Chemistry, Manufacturing, Control)
- Post-Marketing Drug Safety & Pharmacovigilance
- Labeling Updates and Harmonization of Labels
- Product Transfers
- Product Acquisitions (regulatory due diligence)
- Company Mergers
- Company Acquisitions (regulatory due diligence)
- Regional Marketing Deals (co-promotion, co-marketing)
- Coordination of Regulatory Certificates
- Special Projects
info@pharmregservices.com
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