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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 â€‹

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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

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