APAC FDA Consulting Services & Solutions
Facilities Design or Validation
APAC FDA Consulting is skilled in assisting organizations as they encounter facilities design, construction, or adaptation—or as they encounter facilities-related compliance problems.
Through a powerful blend of compliance, regulatory, scientific, and technical expertise, APAC FDA Consulting is highly effective in:
>> Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
>> Developing environmental and processing-room requirements
>> Recommending effective flow of materials, equipment, and personnel
>> Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labeling, and distribution operations
>> Addressing the facilities requirements of laboratory operations
>> Performing factory acceptance testing of equipment (FAT)
>> Conducting audits during construction and installation phases
>> Qualifying facilities for sterile, low-bioburden, and non-sterile products
>> Qualifying facilities for intermediates, APIs, and finished drug products
>> Qualifying facilities for medical device components and finished products
AREAS SERVED BY APAC FDA CONSULTING
ADVANCE. CONFIDENTLY.
As long-standing leaders in technical and regulatory consulting services, APAC FDA Consulting provides both experience and excellence through an unmatched team of respected industry professionals and SMEs.
