STM Pharma Consulting (STM Pharma) offers extensive expertise in the development and successful execution of strategic, operational 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.
In addition to the above, STM Pharma has deep knowledge and expertise offering consulting services to Compounding Pharmacies engaged in the preparation of sterile/high potency drugs (USP <797> & <800>) as well as non-sterile drugs (USP <795>) including bulk preparations as per FD&C Act Section 503B
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)
The principal consultants of STM Pharma, Drs. Waheed Sheikh and Khurshid Iqbal offer 60+ years of combined extensive and proven industry experience in both large and small pharma companies as well as in drug delivery and biotech companies. The latter includes a wide array of R&D drug development companies as well as the CMC contract service providers (CROs and CDMOs). Drs. Sheikh and Iqbal have acquired high level of subject matter knowledge and expertise in the successful CMC development of numerous drug products (both innovative and generics) resulting in regulatory approvals and commercialization.