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 2025
After highly successful inaugural Pharmaceutical Development Conference (PDC) last year, Aphex Pharma Solutions is thrilled to announce that 2nd Pharmaceutical Development Conference (PDC) will be held in Sydney on 9th September 2025 at Holiday Inn Warwick Farm.
18+
Scientific Presentations
18+
Well-known Industry Leaders
4
Scientific Topics
Our Services
Discover our range of professional services tailored to meet your unique requirements.

Quality Management Services
- Vendor Audits
- Mock FDA/TGA/EMA Audits
- Internal Audits
- Risk Management
- FDA Warning Letter (WL) Remediation

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