James McArdle

I offer consulting in pharmaceutical development in the area of chemistry, manufacturing, and control for both small molecules and synthetic oligonucleotides from pre-clinical stages through launch. I provide guidance on regulatory strategy, regulatory documentation, technology transfer, analytical development, stability, drug substance synthesis and scale-up, stability of drug substance and drug product, and sourcing key starting materials and GMP CMOs.

I have extensive experience on ICH Expert Working Groups, including serving as Topic Leader for Q3C, Residual Solvents; Deputy Topic Leader for M4Q, the Quality section of the Common Technical Document; and for Q8, Pharmaceutical Development.

I offer consulting in pharmaceutical development in the area of chemistry, manufacturing, and control for both small molecules and synthetic oligonucleotides from pre-clinical stages through launch. I provide guidance on regulatory strategy, regulatory documentation, technology transfer, analytical development, stability, drug substance synthesis and scale-up, stability of drug substance and drug product, and sourcing key starting materials and GMP CMOs.

I have extensive experience on ICH Expert Working Groups, including serving as Topic Leader for Q3C, Residual Solvents; Deputy Topic Leader for M4Q, the Quality section of the Common Technical Document; and for Q8, Pharmaceutical Development.

I accept both short-term and long-term projects. I charge by time spent on a project, and authorized travel is charged at 1/2 the consulting rate.

My client list includes major multi-national corporations, mid-size companies, and start-ups.

My client list includes major multi-national corporations, mid-size companies, and start-ups.