J Brooks Consulting offers a wide variety of services including the following:
Regulatory Affairs
- Regulatory/medical writing
- IND, NDA, CTD and IMPD submissions
- Regulatory strategy development
- Compliance
- Regulatory operations
Quality Assurance
- GMP, GLP and GCP audits
- Review of contracts and quality agreements
- Batch record review
- Document review and approval
- Warning Letter/483 response
- System implementation
- SOP writing
Clinical Research
- Medical writing
- Clinical site monitoring
- Clinical trial management
- Clinical trial registration
Product Development
- Development strategy (pre-IND to post-marketing)
- Regulatory options and considerations
- Project management
- Operations
J Brooks Consulting is affiliated with other consultants and service providers who provide these and other services. Please contact J Brooks Consulting for more information about the services provided.
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Serving the Pharmaceutical, Biotechnology,
Medical Device and Healthcare Industries
Copyright © 2006-2011 J Brooks Consulting
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