Aphex Pharma Solutions

Welcome to Aphex Pharma Solutions, where our team of highly experienced consultants is dedicated to providing top-notch Pharmaceutical Quality, CMC, and CMC Regulatory services. With over 30 years of experience, we have the knowledge and expertise to help our clients succeed in today's competitive pharmaceutical industry.

Our team's cross-functional experience in quality assurance, GxP auditing, Chemistry Manufacturing and Control (CMC), and CMC Regulatory is unparalleled. We have worked in TGA/APVMA, FDA/CVM, MHRA/VMD, and EMA regulated environments, giving us a comprehensive understanding of the regulatory requirements and guidelines governing the pharmaceutical industry. Our experience extends across drug substance and drug product manufacturing, including injectable, semisolid, liquid, and solid dosage forms.

Contact us if you need help in the following areas;

CMC MANAGEMENT
• CMC project management
• CMC Advisory
• Drug substance development
• Drug product development
• Technology transfer
• Stability management
• CTD Compilation for New Drug Application
• IMPD/IND compilation
• Scientific advice meeting assistance

QUALITY MANAGEMENT
• Vendor audits
• Mock FDA/TGA/EMA audits
• Internal audits:
• FDA Warning Letter (WL) remediation
• Risk Management

Aphex Pharma Solutions is proud host of Pharmaceutical Development Conference which is held annually in Australia. Inaugurated in 2024, PDC attracts delegates from pharmaceutical research and biotech organisations across Australia and overseas.
PDC has presentation tracks in formulation, manufacturing, pre-clinical and clinical development.

PDC has become the most scientific conference in pharmaceutical development sector and brings together the entire pharmaceutical development ecosystem in Australia.
visit the website using the link below and go to PDC tab for more information.

Aphex Pharma Solutions is also the authorised seller of cloudtheapp eQMS.