Global Services & Solutions
Comprehensive Capabilities. Proven Experience.
APAC FDA Consulting offers a full portfolio of FDA compliance consulting, regulatory, and science & technology capabilities to deliver measurable results for clients as they prevent and resolve compliance problems and develop new products for regulatory submission and approval by FDA.
Compliance
Our team of highly experienced experts from the FDA and industry provides a full range of mission-critical services to the regulated industry. We work with clients to design and implement effective and efficient business processes, assuring sustainable compliance through optimal integration of scientific, technical, and regulatory principles.
Data Integrity
Experience excellence in GxP Data Integrity critical to Patient Safety, Regulatory Compliance and Business Success. Make Lachman Consultants’ Data Integrity Services an essential part of your organization’s journey toward a sustainable, compliant, and successful company-wide data governance and integrity program.
Analytical Services
APAC FDA Consulting’ suite of Analytical Services offers unsurpassed accuracy and results in optimum performance and predictable operational execution. Leveraging your data sources to best evaluate the design of protocols, help to reduce complexity while identifying gaps and providing actionable alternatives.
Biomonitoring Support
From initial development to sampling to final release, meeting biopharmaceutical development milestones, and complying with regulatory guidelines demands quality data to aid informed decision-making. APAC FDA Consulting’ wide range of biomonitoring services focus on addressing the challenges of auditing and quantifying identity, purity, quality, safety, efficacy, and many others.
Strategic Planning
The trusted and knowledgeable advisors of APAC FDA Consulting bring decades of industry experience to our entire wide range of strategic and development planning services, helping clients understand market and competitive dynamics and evaluate pipeline viability.
FDA-Related Services
We also offers FDA-related services to clients, such as document preparation/reviews, audits and reviews, compliance problem resolution, training, regulatory affairs strategic assistance, preparation and/or review of regulatory filings, and other special services.
Due Diligence Audits
APAC FDA Consulting completes diligence audits to support strategic mergers and acquisitions.
Quality Assurance and Controls
APAC FDA Consulting provides clients with quality assurance and control offerings, such as evaluation of written procedures and standard operating procedures, development of laboratory systems and specifications, corporate oversight programs, and more.
Scientific and Technical Assistance
APAC FDA Consulting provides clients scientific and technical assistance to resolve complex problems, including a review program for data integrity, as well as other significant scientific and technical challenges.
Systems Evaluation
APAC FDA Consulting offers systems evaluation services, such as R&D manufacturing systems assessments, as well as reviews and recommendations for quality control/quality assurance systems.
Facilities Design and Evaluation
APAC FDA Consulting offers clients facilities design or validation services, including a full complement of capabilities from development of requirements to auditing during construction and installation.
System Process Validation or Qualification
APAC FDA Consulting offers system and process validation or qualification services, including programmatic assistance, computer system validation, and specific validation/qualification activities.
Training
APAC FDA Consulting provides training services, including programs to address compliance and regulatory affairs, as well as custom programs to meet specific requirements.
Remote Services
APAC FDA Consulting is supporting our clients with the same expertise, knowledge, and partnership you experienced before “social distancing” became the most spoke phrase in the English Language.
Areas Served by APAC FDA Consulting
As long-standing leaders in the technical and regulatory consulting services, APAC FDA Consulting provides both experience and excellence through an unmatched team of respected industry professionals and SMEs.