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

Holiday Inn, Warwick Farm, NSW - 9 September 2025

20+

Scientific Presentations

20+

Well-known Industry Leaders

4 Scientific Topics

- Pre-Clinical Development

- Clinical Development

- Formulation Development

- Manufacturing Development

Our Services

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

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Quality Management Services
  • Vendor Audits
  • Mock FDA/TGA/EMA Audits
  • Internal Audits
  • Risk Management
  • FDA Warning Letter (WL) Remediation
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CMC Advisory
  • CMC Project Management
  • Method Development
  • Drug Substance Development
  • Drug Product Development
  • Stability Planning and Program 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