FDA-Related Services

Preventing and resolving compliance issues is at the heart of Lachman Consultants’ experience and expertise. Through our integrated approach, which includes the support of our scientific and technical experts, Lachman is able to provide specific, actionable recommendations to clients. The Lachman team has a stellar reputation for interpreting, addressing, and solving complex problems.

In the realm of FDA-related services, Lachman Consultants offers a diverse portfolio of capabilities:

Document Preparation/Reviews

Lachman has a well-earned reputation for helping to ensure that documents submitted to the FDA are of the utmost quality—helping to accelerate positive outcomes.

Compliance Problem Resolution

Lachman excels at helping clients respond to FDA 483s and FDA warning letters. Just as important, Lachman Consultants have the knowledge and experience to help clients remediate compliance issues and prevent recurrence.

Regulatory Affairs Strategic Assistance

Lachman can assist clients in addressing regulatory affairs requirements—from strategic advice on regulatory filings to evaluation and resolution of complex scientific and regulatory issues.

Training

The expert consultants at Lachman can help train personnel on regulatory affairs matters and specific forms of FDA compliance. Lachman also routinely provides formal policy updates and training.

Audits and Reviews

Leveraging extensive experience in compliance, science, and technology, the Lachman team can perform a wide variety of audits and reviews of good practices for drug and device manufacturing, laboratory management, marketing and promotion, and more.

Other Regulatory Activities

The consultants at Lachman are available to meet a wide range of needs—from communicating with regulatory agencies on behalf of clients to helping clients prepare for FDA meetings.

Pharmacovigilance/Drug Safety Surveillance

Pharamacovigilance and Drug Safety are an area of concern today and Lachman’s expert consultants are ready to help in this area.

Special Services

Lachman Consultants also offers other custom services specific to clients’ needs.