• Development Plan Review Comprehensive assessment of your current botanical drug development roadmap to ensure alignment with scientific and commercial goals.

• IND Gap Analysis Systematic identification of regulatory and data deficiencies within your US FDA IND application to prevent submission delays.

• Strategic Remediation Development of targeted regulatory strategies to close identified gaps and meet FDA compliance standards.

• Project Forecasting Detailed estimation of timelines and costs required to achieve IND readiness, ensuring transparent budget planning.

Analytical Chemistry & Quality Control

• Quantitative Analytics: Comprehensive testing including mass balance, residual pesticides, elemental impurities, and residual solvent analysis.

• Chromatographic Profiling: Advanced HPLC and GC profiling for both drug substances and finished products to ensure purity and consistency.

Non-Clinical Development

• Pharmacology & Efficacy: Studies to define Mechanism of Action (MoA) and validate therapeutic effects.

• Toxicology: Full-spectrum safety assessment including acute, repeat-dose, genotoxicity, and carcinogenicity studies.

• Safety Pharmacology: Core battery testing on vital organ systems (cardiovascular, CNS, and respiratory).

• DMPK / ADME: Pharmacokinetics studies to evaluate absorption, distribution, metabolism, and excretion profiles.

• Know-How: Expertise in developing the most efficient CMC processes to meet the FDA requirement for botanical drug INDs.

• Method Development: Establish QC standards for full-spectrum botanical substances.

• Process Design: Develop and refine scalable manufacturing workflows.

• Product Formulation: Engineer optimized dosage forms and delivery systems.

• Stability Assessment: Conduct rigorous testing to determine product shelf-life.

• IND Package Development Complete preparation, medical writing, and compilation of the Investigational New Drug (IND) application dossier.

• FDA Meeting Management Strategic support for requesting, preparing for, and attending formal meetings with the FDA (e.g., Pre-IND, End-of-Phase 2).

• Submission Execution Management of the formal IND submission process, ensuring all documentation meets formatting and technical requirements.

• Agency Correspondence & Resolution Expert guidance in responding to FDA Information Requests (IRs) and resolving clinical holds or regulatory queries post-submission.