A well-prepared regulatory submission is essential for advancing your drug product from development to human trials. We offer expert consulting for regulatory documentation and Investigational New Drug (IND) application support, specializing in complex formulations such as lipid nanoparticles (LNPs), polymeric systems, and sterile injectables.

With over a decade of experience preparing regulatory dossiers, including CMC sections, we ensure your submission is complete, compliant, and aligned with FDA and global expectations—reducing delays and facilitating clinical approval.

Our IND & Regulatory Support Services

1. IND-Enabling Strategy & Gap Assessment

We evaluate your current development status and guide you through the necessary studies and documentation for a successful IND submission.
Includes:

• Regulatory readiness assessments
• Pre-IND meeting preparation and strategy
• Study planning for toxicology, stability, and analytical validation
• Gap analysis of CMC, pharmacology, and safety data

2. CMC (Chemistry, Manufacturing & Controls) Documentation

We author and review the full CMC module for your IND, ensuring that formulation, manufacturing, and quality systems are accurately and clearly presented.
Includes:

• Description of drug substance and drug product
• Formulation and process development documentation
• Facility information and GMP compliance narratives
• Batch records, process controls, and analytical methods

3. eCTD Submission Support & Document Authoring

We assist in assembling a complete, well-organized electronic Common Technical Document (eCTD) formatted submission ready for FDA or global regulatory agencies.
Includes:

• IND Module 3 (CMC), Module 2.3 (Quality Overall Summary)
• Authoring of quality and technical narratives
• Formatting and organization of submission-ready files
• Collaboration with regulatory publishing teams

4. Regulatory Agency Interaction & Meeting Support

From FDA meetings to global health authority engagement, we help you present your data and strategy with clarity and confidence.
Includes:

• Pre-IND meeting briefing documents
• Preparation of regulatory Q&A and response packages
• Strategic positioning for complex or novel drug delivery systems
• Support during agency feedback and information requests

Why Work With Us

• Specialized expertise: Focused on regulatory development for LNPs, nanoparticle injectables, and emerging drug modalities
• Submission-ready quality: Documents prepared to regulatory standards and formatted for smooth eCTD integration
• Integrated science and compliance: Bridging scientific depth with regulatory precision for clear, compelling submissions
• Proven track record: Experience supporting IND, NDA, and global filings across biotech and pharmaceutical companies

Regulatory Clarity. Clinical Readiness.

Your IND is the gateway to clinical trials. Let us help you prepare a compelling, compliant submission that accelerates your path to the clinic.

📧 Contact us today to discuss your IND strategy or regulatory documentation needs.