PIND & IND Strategic Consulting: Expert guidance on navigating the pre-Investigational New Drug (PIND) and IND pathways, specifically tailored to the unique complexities of botanical drug substances. 

CMC Strategy & Documentation: Development of Chemistry, Manufacturing, and Controls (CMC) dossiers that satisfy FDA requirements for batch-to-batch consistency using a "Totality of Evidence" approach.

Raw Material Qualification: Rigorous assessment and standardization of botanical raw materials, including agricultural controls and botanical identity verification.

Regulatory Meeting Coordination: Management and preparation for formal FDA meetings (Type B and Type C), including the drafting of Briefing Books and technical responses to FDA Botanical Review Team (BRT) inquiries.

Clinical Protocol Alignment: Assistance in designing clinical trials that account for the unique characteristics of botanical mixtures, such as "prior human experience" and the use of traditional preparations in modern research.

IND Packet Compilation: End-to-end support in gathering, organizing, and submitting the full IND application packet through the FDA’s Electronic Common Technical Document (eCTD) gateway.

• Small & Large Molecule Isolation: Precision engineering for the extraction of complex botanical matrices, optimized for yield, purity, and scalability.

• ICH-Compliant Stability: Execution of stability-indicating studies (ICH Q1A-Q1E) to ensure chemical and biological integrity over shelf life.

• Pharmaceutical Certification (CoA): Rigorous documentation of Critical Quality Attributes (CQAs) required for IND/NDA Module 3 dossiers.

Advanced Botanical Profiling

• High-Resolution Deconvolution: Resolving low-abundance metabolites and "masked" peaks often missed by standard full-spectrum chromatography.

• Identification of "Unknowns": Leveraging historical retention databases to structurally elucidate unidentified peaks, a critical FDA requirement.

• Marker Characterization: Transforming undefined chemical noise into "characterized markers" to demonstrate full control over drug composition.

Pharma-Grade cGMP Compliance: Strategic implementation of Current Good Manufacturing Practices (21 CFR Part 210/211) specifically adapted for the unique variability of botanical drug substances and products.

Botanical Raw Material (BRM) Controls: Oversight of agricultural and collection practices (GACP) to ensure the quality, identity, and consistency of biomass before it enters the manufacturing chain.

Process Validation for Complex Mixtures: Development of validated manufacturing processes that maintain the "fingerprint" of the botanical mixture while effectively removing contaminants and ensuring dose uniformity.

"Totality of Evidence" Quality Systems: Establishment of quality control systems that integrate chemical testing, bioassays, and process controls to guarantee therapeutic consistency across batches.

Contamination & Cross-Contamination Mitigation: Specialized facility and equipment protocols designed to manage the high bioburden and potential environmental contaminants inherent in botanical processing.

Stability Program Management: Comprehensive ICH-compliant stability studies for botanical drug substances and products, focusing on the preservation of the chemical and biological profile over the shelf life.

Audit & Inspection Readiness: Preparation of facilities and documentation for FDA pre-approval inspections (PAI), ensuring all manufacturing data is transparent, traceable, and "Data Integrity" compliant.

Technical Transfer Support: Seamless transfer of manufacturing processes from bench-scale to commercial-scale cGMP environments while maintaining the regulatory specifications defined in the IND/NDA.