Businesses in the Life Sciences industry are subject to regulatory oversight to ensure compliance with safety standards for drugs and health products.
Providing advice and guidance to entities in this industry demands a keen appreciation of today’s business realities, industry standards, and a detailed understanding of clients’ regulatory requirements, informed by intimate familiarity with the science and technology that underpin their products.
Yocto advises clients on a variety of regulatory compliance and marketing and advertising matters. Dr. Gabriella Chan holds a Regulatory Affairs Certificate in Medical Devices with a focus on Health Canada and FDA regulations.
Contact Yocto for assistance with:
Regulatory Compliance matters
● Product classification and management of regulatory approval processes including: Medical Device and Cell, Tissue and Organ (CTO) Establishment registrations, licensing applications, and restrictions under Health Canada’s Therapeutic Products Directorate (TPD), Biologics and Genetic Therapies Directorate (BGTD)
● Applications for Manufacturer’s Certificates including exportation of Medical Devices and Quality Management System (QMS) Certificates
● IRB/REB/IEC submissions and human research protections as well as research privacy, compliance, and misconduct matters
● Clinical trials matters including: assisting with clinical trial approval and compliance under the Food and Drugs Act, investigational testing authorizations, preparation and review of clinical trial agreements between sponsors, institutions, investigators, and contract research organizations (CROs)
● Guidance on privacy and access to information matters, audit procedures, export matters, and record keeping obligations
● Compliance with good manufacturing practices (GMP) by fabricators, packagers, and labelers and adherence to good clinical practices (GCP) in clinical trial settings
● Guidance on adverse event reporting, product recalls, and sample distribution and compliance
● Pricing, coverage and reimbursement, and rebate matters
● Matters related to professional allowances and conflicts of interest
● Drafting of product licensing and acquisition, manufacturing, distribution, and quality agreements as well as conducting transactional regulatory due diligence
● Monitoring of Canada’s Special Access Program to drugs and medical devices
Advertising, Labeling, and Marketing
● Drafting and review of print and broadcast advertising (including comparative advertising), package insets, and labeling of consumer products
● The Canadian Code of Advertising Standards, consumer protection legislation, competition law matters, marketing and advertising over the internet, and responding to related complaints by regulators, consumers, and competitors
● Drafting and review of product licence/marketing authorization transfers and promotion, co-promotion, and marketing agreements