Canada: McCarthy Consultant Services Inc

MCSI is a leader in the world of Canadian regulatory affairs for the Medical Device, Pharmaceutical, Biotechnology, Food and Cosmetic industries. Our skilled and knowledgeable associates specialise in regulatory strategic planning, organising and planning Health Canada meetings, preparing and filing Class II, III, and IV Medical Device License applications, Drug Submissions — DINA’s, CTA’s, ND’s, support during Health Canada reviews, label and advertising reviews, regulatory and compliance issues, and quality system audits (QS-GMP-ISO). Furthermore, McCarthy Consultant Services Inc. will act as a legal agent for those Drug companies that do not have offices in Canada.

Services Include:

• Regulatory strategic planning
• Organize and manage TPD meetings
• Prepare and file CTA’s (Clinical Trial Applications)
• Prepare and file Class II, III and IV applications
• Application support during TPD review
• Quality System audits (QS - GMP - ISO - CMDCAS)
• Label and advertising review
• Regulatory compliance issues