Pharma & Life Sciences / Featured expert
Dr Mohammad Ali Danesh
PharmD, PhD, MSc
Pharmaceutical scientist: sterile products, formulation, GMP and root cause analysis
- Based in
- London, United Kingdom
- Licensed judicial expert
- Supreme Council of Official Judicial Experts, Iran (2020)
Biography
A pharmaceutical scientist with a PharmD, a PhD in Pharmaceutics and more than 20 years in the pharmaceutical industry, Dr Danesh has directed the development of sterile products, including lyophilised oncology vials and insulin cartridges, and has led quality assurance, quality control, batch release and GMP audits at a pharmaceutical manufacturer.
Licensed as a judicial expert in 2020, he has acted in disputes over pharmaceutical formulation and investigated an impurity found in a finished sterile injectable medicine, tracing it through root cause analysis to the plant's water purification system. He is now based in London and holds an MSc in International Management from Loughborough University.
Areas of expertise
- Sterile injectable and lyophilised products
- Pharmaceutical formulation and development
- GMP, quality assurance and batch release
- Root cause analysis and impurity investigations
- Pharmaceutical water systems and contamination control
- Tableting and tabletability
Typical instructions
- Disputes over pharmaceutical formulation and product development
- Contamination, impurity and out-of-specification investigations
- GMP compliance, quality systems and batch release
- Technology transfer, scale-up and manufacturing process assessment
Expert witness experience
Dr Danesh qualified as a judicial expert after an entrance examination and two years of supervised training, and was licensed by the Supreme Council of Official Judicial Experts of Iran in 2020. He has since acted in three pharmaceutical formulation disputes and a sterile injectable impurity investigation.
Qualifications
- PharmD, Kerman University of Medical Sciences
- PhD in Pharmaceutics, Tabriz University of Medical Sciences
- MSc International Management, Loughborough University
Licences
- Expert Licence, Supreme Council of Official Judicial Experts of Iran (2020)
FAQ
Common questions
How do I instruct a sterile products expert?
Tell us about the matter using the form on this page: the issues, the forum and any deadline. We check availability and conflicts, then introduce you so you can agree the instruction directly.
What does a GMP expert witness do?
A GMP expert gives the court an independent opinion on whether a manufacturer's processes, controls and quality systems met Good Manufacturing Practice, and on the likely cause of any quality failure.
Does Dr Danesh owe a duty to the court?
Yes. Like every expert instructed through us, his overriding duty is to the court under CPR Part 35, not to the party paying for the report.
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