CANI

MCS Associates Incorporated

Services:

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.

Comments:

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