AUSTAR provided PIC/S Certification Consulting Services for a CDMO enterprise

With the continuous advancement of the pharmaceutical industry, topical formulations have emerged as a focal point of interest for pharmaceutical enterprises and research institutions, driven by their unique therapeutic advantages and broad market demand. These formulations play a critical role in the treatment of dermatological conditions, pain relief, and wound healing promotion, requiring strict adherence to relevant standards and regulations throughout their development and manufacturing processes to ensure product safety and efficacy.

Project Background:
The client is a CDMO enterprise providing comprehensive solutions for external use complex formulations to pharmaceutical companies and research institutions. Its business scope covers the entire process of complex formulation development, integrating a CDMO base into the full pharmaceutical R&D industry chain. The client is committed to achieving seamless connectivity from basic research, technical breakthroughs, to commercial production, creating a CDMO service platform that meets market and customer needs.

AUSTAR Solution:

•        GMP compliance certification consulting services

•        PIC/S compliance certification consulting services

•        On-site gap analysis

•        Comprehensive quality system enhancement

AUSTAR Value & Client Benefits:

•        Met the expectations and requirements of NMPA and PIC/S GMP.

•        Provided phased technical guidance, offering targeted and cost-effective solutions.

•        Enhanced the client's quality management system and personnel skills.

•        Assisted the client in successfully passing registration on-site inspections, domestic GMP compliance                     inspections, and PIC/S compliance certification.