Drug Information Association Logo
Corporate Tagline

McCarthy Consultant Services Inc.

Description: 

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.

Pharmaceuticals

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

Medical Devices

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

Services: 

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

Contact Information: 

McCarthy Consultant Services Inc.
1151 Gorham Street, Unit 8
Newmarket, ON, L3Y 8Y1, CAN
Phone : 9058360033
Fax : 9058360006
Internet : www.mccarthyconsultant.com
Email : mccarthy@mccarthyconsultant.com
Contact Person : Matt McCarthy, Vice President & General Manager