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The TRI Bio-Pharmaceutical Development Support Team, with more than 30 dedicated scientists (Ph.D. / M.S. level) and writers with advanced degrees, has the in-house capabilities to assist sponsors with all regulatory aspects of the product development process. Using a model that includes planning, drafting, scientific review, and comprehensive quality checks, our regulatory and medical writing staff produce, maintain & review a wide range of documents relating to clinical trials and associated regulatory submissions. Some of our regulatory services include:
- Development of Regulatory Strategies
- Development of Non-clinical Study Plans
- Pre-IND and IND Meeting Package Preparation and FDA Presentations
- Clinical Protocol Development
- Oversight and Data Review of Active Trials
- Regulatory Review of Clinical Protocols
- IND Preparation & Maintenance including:
- Clinical/Investigator's Brochures
- Chemistry, Manufacturing, and Controls
- Non-clinical Pharmacology and Toxicology
- Previous Human Experience Sections
- Amendments
- IND Annual Report Preparation
- Master File Preparation and Maintenance
- Coordination of Meetings with FDA
- Preparation of FDA Query Response Correspondence
- Execution of Legal, Collaborative Industry Agreements
Our Regulatory Team has access to standard templates that meet regulatory standards and are also practiced in using report templates that may be provided by our clients. Our writers have a variety of software available so that they can provide the reports to the client in whatever electronic or hard copy format may be needed.
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