Supporting Global Drug Manufacturers with Proven Regulatory and Compliance Expertise
Pharmaceutical Consulting
Pharmaceutical companies operate in one of the most highly regulated industries in the world. From early development through commercialization, maintaining compliance with evolving global standards — including FDA, EMA, MHRA, HPRA, PIC/S, and more— is critical to product success and patient safety. Lachman brings over four decades of experience helping pharmaceutical manufacturers navigate quality and compliance complexities with confidence.
Who We Serve
- Pharmaceutical companies
- Generic drug companies
- OTC product companies
- Contract manufacturers (CMOs/CDMOs)
We also work with virtual and emerging pharmaceutical companies.
How We Help
Lachman Consultants offers strategic and technical expertise across the full product lifecycle. Our team includes former regulatory agency officials, regulatory strategists, and quality system architects who understand the nuances of pharmaceutical operations and regulatory expectations.
We help clients:
- Design and optimize quality systems for development and commercial scale
- Conduct mock inspections and audit readiness programs
- Remediate compliance gaps and respond to enforcement actions
- Respond to regulatory feedback, including 483s and Warning Letters
- Develop data governance and integrity frameworks
- Prepare and submit regulatory applications (IND, NDA, ANDA, BLA)
- Train teams on GMP, regulatory affairs, and quality culture
Key Challenges in the Pharmaceutical Sector
- Ensuring inspection readiness and sustained cGMP compliance
- Managing data integrity and digital transformation
- Responding to FDA 483s, Warning Letters, and consent decrees
- Designing scalable, phase-appropriate quality systems
- Aligning global operations with regional regulatory requirements
- Navigating complex regulatory pathways (e.g., 505(b)(2), ANDA, NDA, BLA)