RaQa Consulting Inc (RAQAC) supports manufacturers, importers and distributors in meeting the stringent regulatory requirements of the Canadian health products and food industries in preparation for market approval.
The company is committed to providing comprehensive strategies for regulatory approval and quality operations throughout a product’s lifecycle. RAQAC’s consultants are experienced in working with regulatory, clinical and quality agencies in Canada and other markets.
Regulatory preparation for market approval applications
RAQAC provides guidance on the Canadian market approval of products such as cosmetics, food products, medical devices, natural health products (NHP) and pharmaceutical drugs.
The company’s market access plans aim to prepare product applications in a cost-effective and timely manner, while maintaining compliance with regulatory and quality standards.
Regulatory affairs service
RAQAC’s consultants have extensive knowledge of Canadian regulations and organises applications, cosmetic notifications and submissions for medical devices, prescription and over-the-counter products, as well as natural health product licence applications (PLA) and other government filings.
The company’s services range from conducting business reviews and product feasibility studies to clinical trial applications, ingredient and formulation reviews, and reviewing labelling and advertising for compliance.
Quality assurance and GMP
RAQAC provides a range of audits and support to identify any quality issues and offer innovative solutions. The company also
- Ensures companies meet good manufacturing practice (GMP) standards for pharmaceutical products and NHPs
- Supports initial and outgoing drug and medical device establishment licensing, including NHP site licensing
- Prepares and implements standard operating procedures (SOP) and quality management systems, including recall and complaint management
Project management for regulatory approval applications
RAQAC’s project managers make cost-effective recommendations to meet key timelines.
Highly trained consultants consider cross-functional departments to effectively coordinate strategic regulatory transactions for mergers and acquisitions (M&A), product launches, line extensions and changes to chemistry and manufacturing controls.