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
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.
Quality Management Services
- Vendor Audits
- Mock FDA/TGA/EMA audits
- Internal Audits
- FDA Warning Letter (WL) remediation
- Risk Management
CMC Advisory
- Method Development
- Drug Substance Development
- Drug Product Development
- Stability Planning and Program Management
- CMC Project Management
CMC Regulatory
- CTD compilation for New Drug Application
- IMPD/IND compilation
- Scientific advice meeting assistance
- Pharmaceutical Product Lifecycle Management
Training
- Quality Culture Training
- cGMP Training
- Risk based quality assurance
- Risk based process validation
- CMC Management & IMPD/IND writing
- Risk management techniques
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