Document Review and Preparation

Lachman Consultants has assisted hundreds of domestic and international clients in reviewing and preparing key documents for review by FDA, including:
  • NDAs
  • INDs
  • ANDAs
  • NADAs
  • 510ks
  • PMAs
  • DMFs

Lachman also has extensive experience in:

  • Developing effective systems to comply with the requirements for adverse drug event (ADE) management and reporting
  • Reviewing product labeling, advertising, and promotional materials for regulatory compliance
  • Providing technical writing for protocols, reports, specifications, policies, and procedures
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.
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.
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.
Training
The expert consultants at Lachman can help train personnel on regulatory affairs matters and specific forms of FDA compliance. Lachman also routinely provide formal policy updates and training.
Special Services
Lachman Consultants also offers other custom services specific to clients’ needs.
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.