Lachman Consultants Services & Solutions
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 FDA Consulting 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:
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
Resolving compliance problems is where Lachman Consultants truly shines. Lachman is the “go-to” firm when organizations are facing difficult challenges and has earned a solid reputation for delivering high-quality insight and recommendations to overcome those challenges. Choose Lachman Consultants when you need help:
- Responding to an FDA 483 inspection
- Responding to an FDA Warning Letter
- Meeting with the FDA to resolve disputes
- Implementing corrective and preventive action (CAPA) programs-including development, execution, monitoring, and project management
- Requiring the assistance of “a third-party role under a consent decree”
Consider enlisting the help of Lachman Consultants to assist with various Regulatory Affairs challenges. The Lachman team stands ready to support needs for:
- Advice and assistance on regulatory filings
- Due diligence for strategic acquisitions and mergers
- Assistance with strategic alliances, including reviewing agreements and contracts to ensure the adequacy of regulatory provisions
- Addressing citizen petitions
- Formulating strategies for patents/exclusivity
- Evaluating and resolving complex scientific and regulatory compliance issues
Lachman Consultants routinely prepares and delivers training programs on the following topics related to the FDA:
- Regulatory affairs
- FDA guidance
- Policies and policy updates
- Current FDA trends and industry/FDA actions
- Risk management
- GMP, GCP, GLP
- Quality Control Laboratory’s operations
Lachman Consultants can also develop custom programs to meet clients’ unique training requirements.
Lachman Consultants can assess organizations’ compliance with:
- GMP (good manufacturing practice) for intermediates, active pharmaceutical ingredients (APIs), and finished drug products
- Q SR (medical device “GMP”)
- GCP (good clinical practice)
- GLP (good laboratory practice)
- GPP (good promotion practice)
- DEA (Drug Enforcement Agency)
Lachman also has extensive experience in:
- Performing “mock” FDA pre-approval inspections-helping to ensure that problem areas are identified and addressed before the real inspection
- Developing drug diversion prevention and counterfeit investigation programs
- Auditing adverse drug event (ADE) programs-from collection and evaluation through reporting and follow-up
- Qualifying vendors
- Performing due diligence
- Conducting regulatory audits
- Auditing documentation, including application integrity audits
- Verifying activities of the regulatory committee
Lachman Consultants provides a wide range of support for diverse regulatory initiatives and activities. Lachman is frequently called upon to represent clients with the FDA and other regulatory bodies, and to help clients prepare or correct regulatory filings. Lachman has extensive experience:
- Communicating with regulatory agencies
- Acting as FDA liaison for international and domestic clients
- Preparing ANDAs, NDAs, DMFs, and other regulatory applications
- Reviewing advertising and promotional materials
- Assisting with drug listings
- Preparing FDA meeting requests and requisite briefing packages
- Performing on-site regulatory assistance
- Preparing standard operating procedures
- Delivering on-site training on regulatory topics
- Attending FDA meetings on our clients’ behalf; assisting with preparatory work such as meeting request and briefing package preparation
Lachman Consultants also delivers other FDA-related services to clients, including:
- Provide assistance
- Manage, oversee, and remediate consent decrees
- Provide on-site interim operational and management support
- Provide strategic guidance and hands-on support for virtual companies
