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Botanical Drug Services

Botanical drugs are botanical products that intend to diagnose, cure, mitigate, treat, or prevent disease in humans, under section 505 of the FD&C Act.  This applies to both research and commercial products.  If you are a researcher who aims to clinically investigate the efficacy potential of a botanical product in the treatment or prevention of disease, you are no longer classified as a dietary supplement and you will need to submit an Investigational New Drug (IND) application.  Please click here for more information regarding the regulation of clinical trials on herbal products.

The regulations of botanical drugs are synonymous with pharmaceutical drugs with variances to accommodate the complex, poly-molecular structure of botanical drug products.  The most challenging and complex component of a botanical drug regulatory submission is the Chemistry, Manufacturing, and Controls (CMC).  It is estimated that 75% of botanical drug IND’s are put on clinical hold because of deficiencies in CMC data.   BRC has the expertise to support the development of your CMC for a botanical drug product, with their  background in analytical chemistry as well as regulatory affairs. 

 
 
 
 
 

Clinical Trials

  • Develop and Write Clinical Trial Protocols

  • Develop and Write IRB Submissions

  • Compliance to Good Clinical Practices (GCP) and Good Documentation Practices (GDP) 

Medical Writing- Regulatory Submissions

  • Develop and Write Investigational New Drug (IND) Application

  • Develop and Write Orphan Drug Designation

  • Develop and Write Expedited Regulatory Review Designations

CMC Development

  • Develop and Write CMC for Regulatory Submission

  • Audit current data package and provide GAP assessment of deficiencies in data

  • Audit current analytical testing practices for accuracy and precision of data

Good Practices Compliance

  • Good Manufacturing Practices: cGMP

  • Good Agricultural and Collection Practices: GACP

  • Good Laboratory Practices: GLP

  • Good Documentation Practices: GDP

  • Good Clinical Practices: GCP

483 Remediation- Warning Letters

  • Prepare for FDA Inspection- Conduct Internal Audits

  • Write and Develop effective CAPA (Corrective and Preventive Action) Plan

  • Government Representation