BRC CONSULTING SERVICES
Botanical Regulatory Consulting (BRC) offers Regulatory, Strategic, and Technical Development Consulting Services.
BRC's primary products are CNS botanical drugs, offering strategic development support and regulatory/scientific review. BRC also offers medical writing services for any stage of botanical drug development.
Clinical Development
Design, Review, and Guide Clinical Study Protocols
Prepare Clinical Study Reports and Interpret Study Data
Prepare Investigator's Brochure and Review ICF
Design, Review, and Guide Documents for Ethics Review
Medical Writing- Clinical Study Documents
Regulatory Affairs
Develop Regulatory Strategy for Product Market Approval
Research and Review Regulatory Assessment of Botanical Product
Develop and Prepare Meeting Materials for Regulatory Authority Meetings
Representation at Regulatory Authority Meetings
Medical Writing-Regulatory Submissions
CMC Support
Guidance and Expertise on cGMP Design and Implementation
Strategy and Development of Analytical Data
Strategy and Development of Extraction Technology
Source Laboratory Services for CMC Regulatory Requirements
Medical Writing - Source Documentation and SOP's
Early Drug Development
Research and Review Nonclinical Toxicology Data for Botanical Drug
Research and Review PK/PD Profile of Botanical Product
Design, Review, and Guide Nonclinical IND Submissions
Source Laboratory Services for Nonclinical Botanical Products
Medical Writing- Nonclinical Regulatory Submissions