Consulting, Contract Auditing, GMP Compliance, Medical Devices/Combination Products, Quality Assurance/Control, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation, Rx to OTC Switch, Standard Operating Procedures, Training
Since 1981, McCarthy Consultant Services Inc. has been a leading company of specialists in Canadian regulatory affairs and quality assurance for the pharmaceutical, medical device, Natural Health Product and biotechnology industries. At McCarthy Consultant Services, we understand the industry need for expert assistance and that’s why our Associates are all former Health Canada or well experienced industry veterans to provide you with knowledgeable, professional expertise that you can trust.
New Drug Submissions (NDS), Supplemental New Drug Submissions (S/NDS), Clinical Trials Applications (CTA), Applications for D.I.N. numbers, Preparation of Plant Master Files, Preparation of Drug Master Files (USA), Provincial Formulary Submissions, Labelling and Advertising Reviews, GMP Audits, ISO 9000 Audits, GMP Training, QA Systems Design and Management, Government Liaison and Strategy, Validations
Device licence submissions and device establishment licence applications, Regulatory compliance trouble shooting, Regulatory Strategy, Quality System audits (GMP and ISO), SOP writing, Validations
Natural Health Products
NHP Compliance Issues, Site Licencing, Reviewing Ingredient Declarations, Determination of Allowable Claims, Compliance Review of Labels, Bilingual Translations, Advertising Copy Review, Approvals of Electronic Advertising Copy, Government Liaison and