Pharmaceutical Quality, CMC and CMC Regulatory Services

With 30 years of expertise, you can rely on.
Your partner in Pharmaceutical Quality, CMC and regulatory solutions

ManDotted

Pharmaceutical Development Conference 2024

After successfully organising Aphex Pharma Solutions CMC and Quality Culture seminars in Melbourne, Sydney, Brisbane, Auckland, and Singapore, Aphex Pharma Solutions is hosting Australia’s first Pharmaceutical Development Conference (PDC) 2024.

20+

Scientific Presentations

20+

Well-known Industry Leaders

4

Scientific Topics

Our Services

Discover our range of professional services tailored to meet your unique needs.

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Quality Management Services
  • Vendor Audits
  • Mock FDA/TGA/EMA audits
  • Internal Audits
  • FDA Warning Letter (WL) remediation
  • Risk Management
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CMC Advisory
  • Method Development
  • Drug Substance Development
  • Drug Product Development
  • Stability Planning and Program Management
  • CMC Project Management
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CMC Regulatory
  • CTD compilation for New Drug Application
  • IMPD/IND compilation
  • Scientific advice meeting assistance
  • Pharmaceutical Product Lifecycle Management
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Training
  • Quality Culture Training
  • cGMP Training
  • Risk based quality assurance
  • Risk based process validation
  • CMC Management & IMPD/IND writing
  • Risk management techniques
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Recruitment
  • Recruitment Assistance for Officer, Manager and Director Level positions in the areas below
  • Quality Assurance and Quality Control
  • Regulatory Affairs
  • Manufacturing
  • MS&T and R&D