Since 1978, Lachman Consultants’ multidisciplinary team of highly experienced FDA and industry experts has offered compliance, regulatory affairs, and technical services to clients around the world. We offer a full portfolio of FDA-related services to deliver measurable results for clients as they prevent and resolve compliance problems and develop new pharmaceutical products for regulatory submission and approval by FDA.
Our FDA and industry experts have extensive experience with FDA and other global regulatory authorities, as well as knowledge of what regulators expect from pharmaceutical companies. Lachman offers a full spectrum of FDA-related services and employs an integrated approach—that incorporates the support of our scientific and technical experts—to provide specific, actionable recommendations to our clients. The Lachman FDA Consulting Team has a stellar reputation for interpreting, addressing, and solving complex problems.
Our diverse portfolio of capabilities includes:
- Responding to FDA 483s, inspections, Warning Letters and other compliance issues, meeting with FDA to resolve disputes, implementing corrective and protective action (CAPA) programs, and assisting with “a third-party role under a consent decree”
- Document preparation and review (including NDAs, INDs, ANDAs, NADAs, and DMFs)
- Compliance with adverse drug event (ADE) management/reporting
- Review of product labeling, advertising/promotional materials for regulatory compliance
- Regulatory affairs consulting with strategic assistance
- Preparation of protocols, reports, policies, etc.
- Training on FDA-related topics (including fully custom programs to meet client needs)
The Lachman Consultants team also offers proactive strategies to help clients stay ahead of the curve, including:
- GxP Audits and Reviews (including mock FDA Pre-Approval inspections, auditing programs, conducting regulatory audits and more)