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-we're able to provide specific, actionable recommendations to our clients. Indeed, our 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 Review and Preparation. 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.
- Audits and Reviews. Leveraging our extensive experience in compliance, science, and technology, our 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.
- Compliance Problem Resolution. Lachman excels at helping clients respond to FDA 483s and FDA warning letters. Just as important, we have the knowledge and experience to help clients remediate compliance issues and prevent recurrence.
- Training. Our seasoned experts can help train personnel on regulatory affairs matters and specific forms of FDA compliance. We also routinely provide formal policy updates and training.
- Regulatory Affairs Strategic Assistance. Lachman can assist you in addressing regulatory affairs requirements — from strategic advice on regulatory filings to evaluation and resolution of complex scientific and regulatory issues.
- Other Regulatory Activities. The consultants at Lachman are available to meet a wide range of needs — from communicating with regulatory agencies on behalf of our clients to helping you prepare for FDA meetings.
- Special Services. Lachman Consultants also offers other custom services specific to our clients' needs.
