Experience excellence in technical, regulatory consultation, and guidance services for Biologics and Biotechnology.

Consultation, Services and Support from a Trusted Partner

APAC FDA Consulting brings both experience and excellence to its Biologics and Biotechnology Consultation Services. Through a dedicated single point of contact, multidisciplinary groups of accomplished FDA and industry experts are assembled from our Compliance, Regulatory, and Science and Technology Practice Groups. These comprehensive teams are selected and assigned based on each client’s unique set of objectives, needs, and circumstances.

Our expertise and knowledge, gained through decades of experience, is evident throughout our extensive quality systems, protocols and procedures. APAC FDA Consulting is well-prepared to serve the needs of companies developing biological products, as well as those whose products are transitioning from NDAs to BLAs. We are ready to serve clients with required reporting, documentation, and pre- and post-approval changes.eeds.

APAC FDA Consulting Biologics and Biotechnology Services and Features Provide Support for CDER-, CBER-, and CDRH-Regulated Products, including:

>> GMP Audits
>> Quality Management System (QMS) Assessment
>> Continuous Improvement
>> Regulatory Transitions of HCT/P’s to Drug Products
>> Manufacturing Technology Transfers
>> FDA Meeting Preparation
>> FDA Document Preparation
>> Testing Assessment and Guidance
>> CGMP Facility Audits
>> FDA Inspection Preparation
>> Data Governance and Data Integrity
>> Due Diligence Assessments
>> Monoclonal Antibodies
>> Growth Factors
>> Replacement Enzyme Therapies
>> Peptides
>> In vitro Diagnostics
>> Cellular and Tissue-Based Therapies