MCS Associates Incorporated


MCS provides regulatory affairs advice in the area of OTC Pharmaceuticals, dietary supplements and cosmetics. The advice spans pre-market notification (pre-market approvals, evidence substantiation) to cGMP programs for fabricators, packager/labelers, importers and distributors and post-market surveillance programs for reporting adverse events. Our services include technical writing (SOPs, Protocols); technical reviews (labeling and advertising); and liaison work with the Natural Health Products Directorate in Canada.

Areas of Expertise:

Our professional staff is comprised of senior consultants; technical support staff in the area of regulatory affairs related to pharmaceuticals, dietary supplements and cosmetics. Our main area of expertise is product registration and cGMP programs.


Our experience lies at the intersection between regulatory affairs, analytical chemistry and microbiology.