BRC CONSULTING SERVICES
Botanical Regulatory Consulting (BRC) offers Regulatory, Strategic, and Technical Development Consulting Services.
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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​
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Prepare Clinical Study Reports and Interpret Study Data​
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Prepare Investigator's Brochure and Review ICF​
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Design, Review, and Guide Documents for Ethics Review​
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Medical Writing- Clinical Study Documents​
Regulatory Affairs
Develop Regulatory Strategy for Product Market Approval​
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Research and Review Regulatory Assessment of Botanical Product
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Develop and Prepare Meeting Materials for Regulatory Authority Meetings ​
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Representation at Regulatory Authority Meetings​
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Medical Writing-Regulatory Submissions​
CMC Support
​​Guidance and Expertise on cGMP Design and Implementation​
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Strategy and Development of Analytical Data​
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Strategy and Development of Extraction Technology
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Source Laboratory Services for CMC Regulatory Requirements​​
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Medical Writing - Source Documentation and SOP's​
Early Drug Development
Research and Review Nonclinical Toxicology Data for Botanical Drug ​
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Research and Review PK/PD Profile of Botanical Product​
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Design, Review, and Guide Nonclinical IND Submissions
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Source Laboratory Services for Nonclinical Botanical Products​
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Medical Writing- Nonclinical Regulatory Submissions