Regulatory Service

Development Plan Review

A thorough gap analysis is the critical first step in any successful botanical drug development program. ABDC's structured gap analysis services identify regulatory and scientific deficiencies before they become costly FDA clinical holds or submission delays.

• Development Plan Review

Comprehensive assessment of your botanical drug development roadmap against the FDA's 2016 Botanical Drug Development Guidance, ensuring alignment with both scientific standards and commercial objectives.

• Botanical IND Gap Analysis

Systematic, line-by-line evaluation of your planned or existing IND application to identify regulatory deficiencies across CMC, nonclinical, and clinical sections — the most common sources of FDA information requests in botanical drug submissions.

• Strategic Regulatory Remediation

Development of targeted, prioritized action plans to close identified gaps and achieve full FDA compliance, with clear guidance on the most efficient remediation strategies for botanical drug programs.

• Project Forecasting

Detailed, milestone-based estimation of the timelines and costs required to reach botanical IND readiness — providing sponsors, investors, and development teams with the transparency needed for confident resource planning.

Analytical Chemistry & Quality Control

Robust analytical chemistry is the backbone of a defensible botanical IND submission. ABDC supports sponsors in establishing the analytical foundation required by the FDA for botanical drug substances and finished drug products:

• Quantitative Analytics: Comprehensive testing programs covering mass balance, residual pesticides, elemental impurities, and residual solvent analysis — all critical quality attributes for botanical drug IND submissions.

• Chromatographic Profiling: Advanced HPLC and GC-based profiling of botanical drug substances and finished products to establish chemical fingerprints, confirm batch-to-batch consistency, and support botanical API characterization.

Nonclinical Development

• Pharmacology & Efficacy Studies: Mechanism of action (MoA) elucidation and therapeutic efficacy validation in relevant pharmacological models, designed to support the botanical IND clinical rationale.

• Toxicology: Full-spectrum GLP-compliant safety assessment including acute toxicity, repeat-dose toxicity, genotoxicity, and carcinogenicity studies, structured to meet FDA botanical drug nonclinical requirements.

• Safety Pharmacology: Core battery testing of vital organ systems — cardiovascular, CNS, and respiratory — in compliance with ICH S7A/S7B guidelines.

• DMPK / ADME: Pharmacokinetic studies evaluating the absorption, distribution, metabolism, and excretion profiles of botanical marker compounds and extracts.

Chemistry, Manufacturing, and Controls (CMC) is consistently the most challenging section of a botanical IND submission. ABDC provides end-to-end CMC development support specifically designed for the complexity of botanical drug substances and drug products:

• CMC Strategy & Know-How: Expert guidance on developing the most efficient, FDA-compliant CMC processes for botanical drug INDs — drawing on hands-on experience with botanical extraction, purification, and standardization at both laboratory and industrial scale.

• Analytical Method Development & Validation: Establishment of validated QC methods for full-spectrum botanical drug substances, including fingerprinting assays, potency markers, and impurity methods.

• Manufacturing Process Design: Development and optimization of scalable botanical drug substance manufacturing workflows, with particular expertise in identifying and resolving lab-to-industrial scale-up challenges.

• Drug Product Formulation: Engineering of optimized dosage forms and drug delivery systems for botanical APIs, balancing bioavailability, stability, and patient acceptability.

• Stability Assessment: Rigorous stability studies conducted under ICH-defined conditions to establish shelf-life specifications for botanical drug substances and finished drug products.

A successful botanical IND submission requires meticulous preparation, precise medical writing, and expert management of the FDA interaction process. ABDC provides comprehensive IND submission services for botanical drug programs:

• IND Package Development: Complete preparation, medical writing, and compilation of the botanical IND application dossier — including all CMC, nonclinical, and clinical sections — in full compliance with FDA formatting and content requirements.

• FDA Meeting Management: Strategic support for requesting, preparing, and executing formal FDA meetings — including pre-IND meetings and End-of-Phase 2 meetings — critical milestones in the botanical drug development timeline.

• IND Submission Execution: End-to-end management of the formal botanical IND submission process, ensuring all documentation meets FDA electronic submission standards and technical requirements.

• Agency Correspondence & Clinical Hold Resolution: Expert guidance in preparing responses to FDA Information Requests (IRs), resolving clinical holds, and managing ongoing regulatory correspondence throughout the botanical drug development lifecycle.