Untitled design.png

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) 

Read More

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

Read More

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

Read More

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

Read More

483 Remediation- Warning Letters

  • Prepare for FDA Inspection- Conduct Internal Audits

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

  • Government Representation

Read More