• 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.

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.

Gap Analysis & Data Review: Comprehensive review of existing pharmacological and toxicological data to identify hurdles and streamline the transition from dietary supplement or traditional use to a regulated drug candidate.

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.

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.