BRC CONSULTING SERVICES
Botanical Regulatory Consulting (BRC) offers Regulatory, Strategic, and Technical Development Consulting Services.
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BRC's primary products are botanical drugs, offering strategic development support and regulatory/scientific review for novel therapeutics
Clinical Development
Design, Review, and Guide Clinical Study Protocols​
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Design, Review, and Guide Clinical Study Documents​
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Design, Review, and Guide Documents for Ethics Review
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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​​​Representation at Regulatory Authority Meetings​
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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​​​​
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​
​​For a complete overview of our consulting services, please schedule a complimentary consultation with our principal consultant.