STM Pharma Consulting, LLC

Experts in Sterile & Topical Products plus Microbiology

STM Pharma Consulting (STM Pharma) offers extensive expertise in the development and successful execution of strategic, operational, quality and regulatory plans for CMC (chemistry, manufacturing & control) product development of a variety of dosage forms, especially, sterile drug products, topical drug products and solid oral dosage forms plus special expertise in all aspects of microbiology.

STM Pharma has comprehensive experience in  successful product  development , clinical manufacture, commercial manufacture and quality control  of a variety of dosage forms.  This includes pertinent knowledge and vast industry experience  in Parenteral, Oral and Topical Dosage Forms, Formulation Development, Scale-up, Microbiology, Manufacturing, Quality Control, GMP-Compliance and  Regulatory Documentation (INDs, NDAs, ANDAs)

STM Pharma assists virtual, small and mid-size pharma and biotech companies in the process of identification, evaluation and selection of Contract development/manufacturing organizations, Contract Analytical & Microbiology laboratories, GMP storage, Technical and Project management services, GMP audits of the sites, and Pre-approval inspection readiness.