FDA Regulatory Consulting Services

Expert FDA Submission & Compliance Support

At Catain, we specialize in U.S. FDA regulatory consulting services to help pharmaceutical, biotech, and life sciences companies successfully navigate the FDA approval process. From regulatory strategy and submissions (IND, NDA, ANDA, DMF, 505(b)(2)) to FDA compliance and lifecycle management, we provide end-to-end support tailored to your product’s needs.

Our proven track record includes successful first-cycle approvals, timely responses to FDA queries, and eCTD publishing for clients worldwide.

Our FDA Regulatory Consulting Services

FDA Regulatory Strategy & Roadmap

• Customized FDA regulatory roadmaps for drug development.
• Gap analysis and risk assessment to anticipate FDA requirements.
• Guidance on expedited FDA pathways: Fast Track, Breakthrough, Orphan Drug, 505(b)(2).
• Preparation and support for pre-IND, Type B, and Type C FDA meetings.

FDA Submission Preparation & eCTD Publishing

• Investigational New Drug (IND) submissions.
• New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA).
• Drug Master File (DMF) preparation, updates, and maintenance.
• 505(b)(2) applications for drug repurposing and reformulations.
• High-quality regulatory writing and eCTD publishing services.

FDA CMC (Chemistry, Manufacturing, and Controls) Consulting

• Authoring CMC sections for IND, NDA, ANDA, and DMF submissions.
• Process validation, method validation, and stability studies.
• GMP compliance consulting for manufacturing sites.
• Quality by Design (QbD) strategies for robust product development.

FDA Clinical & Non-clinical Consulting

• Toxicology and pharmacology strategies for FDA submissions.
• Clinical protocol design and bioequivalence study support.
• FDA guidance on biowaiver studies and bioanalytical requirements.
• Clinical Trial Application (CTA) preparation and submission.

FDA Compliance & Post-Approval Services

• Annual reports, supplements, and amendments for FDA filings.
• Labeling compliance, safety updates, and post-market surveillance.
• FDA inspection readiness and remediation for 483s and warning letters.
• Lifecycle management and regulatory compliance monitoring.

Why Choose Catain?


• Proven FDA experience across INDs, NDAs, ANDAs, DMFs, and 505(b)(2) submissions.
• Expertise in FDA guidances, CFR regulations, and ICH standards.
• U.S. and global regulatory teams for round-the-clock support.
• Cost-effective solutions for startups, generic companies, and global firms entering the U.S. market.
• Strong record of FDA compliance consulting and submission success.

Get FDA Approval with Confidence


At Catain, we guide your team through every step of the FDA drug approval process—ensuring your submissions are accurate, compliant, and submission-ready on time. 

Contact us today to schedule a consultation with our FDA regulatory experts.