Strategic Compliance and Regulatory Support for Cell & Gene Therapies and ATMPs

CGT & Advanced Therapies

Advanced therapies, including cell and gene therapies, tissue-engineered products, and other ATMPs represent a transformative frontier in medicine. These products offer unprecedented potential for treating rare and chronic diseases, and previously untreatable conditions, but they also introduce complex regulatory, manufacturing, and quality challenges.

Lachman Consultants supports developers of advanced therapies with deep expertise in FDA CBER/CDER and EMA ATMP frameworks, helping companies navigate early development, clinical trials, commercialization, and post-market compliance. Our multidisciplinary teams deliver strategic guidance and technical execution tailored to the unique demands of these innovative modalities.

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Who We Serve

  • Cell and gene therapy developers (autologous and allogeneic)
  • ATMP manufacturers and sponsors
  • Regenerative medicine and stem cell therapy companies
  • Viral vector and plasmid producers
  • CDMOs supporting advanced therapy programs
  • Biotech startups and academic spinouts

How Lachman Supports Advanced Therapy Clients

Lachman Consultants brings together compliance, quality, and scientific experts to support advanced therapy programs from concept to commercialization. Our teams are experienced in both U.S. and EU manufacturing compliance and regulatory pathways, and we understand the nuances of emerging and novel technologies.

We help clients:

  • Develop regulatory strategies for IND, BLA, CTA, and MAA submissions
  • Prepare for FDA and EMA milestone meetings and expedited pathways (RMAT, Breakthrough, PRIME)
  • Design and implement phase-appropriate quality systems for CGT manufacturing
  • Conduct GMP readiness assessments and inspection preparedness for early and late-stage facilities
  • Support with end‑to‑end CMC guidance—from development through commercialization
  • Perform contamination control and risk assessments aligned with Annex 1 and ATMP-specific guidelines
  • Support data governance, integrity, and documentation for complex biologics
  • Evaluate and qualify third-party CMOs, suppliers, and technology platforms

Key Challenges in the Advanced Therapy Sector

  • Navigating divergent FDA and EMA regulatory expectations for CGTs and ATMPs
  • Establishing phase-appropriate GMP systems for early-stage therapies
  • Managing chain-of-identity and chain-of-custody for autologous products
  • Addressing long-term follow-up (LTFU) and post-market surveillance requirements
  • Validating complex manufacturing processes and analytical methods
  • Responding to evolving guidances on genome editing, CAR-T, and viral vector safety
  • Preparing for regulatory meetings (INTERACT, pre-IND, pre-BLA, scientific advice)