The Chemistry, Manufacturing, and Controls (CMC) section is the cornerstone of every regulatory submission, detailing the composition, formulation, manufacturing, and quality assurance of your drug product. We provide comprehensive CMC consulting services to ensure your data, documentation, and strategy are fully aligned with FDA, EMA, and global regulatory expectations.

Specializing in advanced drug delivery systems—including lipid nanoparticles (LNPs), polymeric nanoparticles, and sterile injectables—we help clients build complete, compliant, and strategically structured CMC packages from early development through commercialization.

Our CMC Consulting Services

1. CMC Strategy & Planning

We design a clear, phase-appropriate CMC roadmap that aligns with your product development and clinical timelines.
Includes:

• Pre-IND CMC planning and risk assessment
• Phase I/II/III CMC strategies for nanomedicine and biologics
• Regulatory authority engagement support (FDA, EMA, MHRA)
• Global CMC harmonization planning for multiple markets

2. Formulation & Process Documentation

We develop the required documentation to clearly define your drug substance and drug product, process controls, and manufacturing workflow.
Includes:

• Description of drug substance and excipients
• Drug product formulation and manufacturing process flow
• Critical process parameters (CPPs) and in-process controls
• Container closure systems and sterilization methods

3. Analytical Methods & Quality Standards

We define the control strategies needed to ensure product quality and regulatory compliance throughout the product lifecycle.
Includes:

• Analytical method development, qualification, and validation
• Definition of specifications and acceptance criteria
• Raw material and excipient qualification
• Stability testing and shelf-life justification

4. CMC Section Authoring for Regulatory Submissions

We provide full authoring and technical review for CMC modules of regulatory dossiers, formatted for global submission standards.
Includes:

• IND, IMPD, NDA, and BLA Module 3 authoring
• Quality Overall Summary (Module 2.3)
• Formatting for eCTD submission readiness
• Review of supporting documents and third-party data integration

Why Work With Us

• Specialized knowledge: Deep experience in nanoparticle formulations and complex sterile products
• Regulatory fluency: CMC packages aligned with ICH Q8, Q9, Q10, and Q11 guidelines
• End-to-end support: From preclinical formulation to commercial GMP filings
• Track record of success: Supported INDs, NDAs, and global CMC compliance for clinical-stage and commercial products

Your Innovation Deserves Regulatory Precision

Let us help you build a CMC package that tells the full story of your product—with scientific clarity, manufacturing rigor, and regulatory confidence.

📧 Contact us to schedule a CMC consultation and move forward with confidence.