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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

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