Biotechnology

APAC FDA Consulting has a reputation for demonstrated excellence in technical, regulatory consultation, and guidance services for biologics and biotechnology. Our experts have the knowledge and foresight to keep pace with the continually changing world of pharmaceuticals, biotechnology and biologics, including closely monitoring the ever-changing landscape of new regulations that may present myriad challenges for our biotechnology clients.

In addition to the services outlined below, our team is at the ready to provide custom services and solutions to suit clients’ specific needs.

APAC FDA Consulting offers the following services for our biotechnology clients:

>> Compliance for biopharmaceuticals, combination products, and diagnostic products
>> cGMP Audits and pre-inspection preparation
>> Continuous Improvement
>> Due diligence assessments
>> Consultation and support for generics and biosimilars
>> Assistance with regulatory activities including pre- and post-approval submissions, strategic planning, and FDA meeting preparation
>> Regulatory strategies for transition of HCT/Ps to drug products