AM Life Science Prepares Biotech Company for FDA Audit

AM Life Science (AMLS) is providing program solutions to a prominent biotech company in the Northeastern United States in preparation for an FDA Pre-Approval Inspection (PAI) to achieve commercial approval of a new recombinant biologic.

As a Life Science industry leader, AMLS understands the challenges involved in bringing a new biopharmaceutical manufacturing process online.  In addition to ensuring the implementation of optimal manufacturing and process control, AMLS places a heavy focus on the development of robust quality lifecycle systems to support that process and ensure continued drug product quality for the life of the facility.

“Leveraging our experience over the years with world-class companies and individuals, we have the ability to draw from a wide base of knowledge and have developed a keen eye for detail.  Together, that translates to higher quality standards and greater drug productSafety, Integrity, Strength, Purity and Quality.” says Rod Azadan, Head of AM Life Science.

For a partner who fully understands the critical role an FDA audit plays in bringing a drug to market and works as hard as you do, Contact AMLS Today!