Draco Associates offers hands-on regulatory affairs and quality assurance services, outsourcing, and consulting.

Our international and Canadian clients are typically manufacturers or distributors of pharmaceuticals, natural health products, medical marijuana, medical devices, biologics, or cosmetics, selling or planning to sell in Canada.

Experienced

Draco's associates each have between 10 and 30+ years of experience meeting Canadian regulatory affairs and quality assurance requirements of the Health Protection Branch and Natural Health Products Directorate.

We have been operating for nearly twenty years.

Experts

Draco's clients around the world employ our practical, cost-effective solutions to meeting regulatory requirements and maintaining high product quality.

We can help your company too, and would welcome your call

 

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Draco Associates is experienced at filling voids in the regulatory affairs (RA) and quality assurance (QA) management of manufacturers and distributors. If your company needs a regulatory affairs consultant, or a quality assurance consultant, or an outside source of hands-on services in these functions, we can help with

• overcoming staffing shortages or knowledge gaps
• fully or partially managing regulatory affairs (RA) and quality assurance (QA) functions
• training employees in GMP and QA
• providing independent audits, and support during government audits
• designing QA procedures and related compliance documents
• integrating or developing information-handling systems

We provide support for outsourcing some or all of a company's RA and/or QA services and management functions.

Although Draco was formed nearly twenty years ago to serve the pharmaceutical industry, the expanding regulation of cosmetics, medical devices, and especially natural health products has significantly expanded our practice. We are among the most experienced people in Canada in the still-evolving area of natural health product regulatory affairs and natural health product quality assurance. We have prepared thousands of natural health product license applications and hundreds of site license applications on behalf of clients from around the world.

Draco's associates are also already experienced working with Canada's new Marihuana for Medical Purposes (MMP) regulations. Our pharmaceutical and natural health products background provides solid foundation for supporting the Quality Assurance/GxP requirements for medical marijuana. We have direct experience with planning and preparing the QA Pre-Licensing Report required for the MMP application. We are providing ongoing services to successful licensees to ensure that their operations can pass government inspections without business interruption.

However we don't just fill out paperwork. We work with all our clients to ensure that label content (including translations), packaging components, facilities and procedures, product monographs, and even product ingredients, are likely to meet requirements before submitting a DIN application or product license application or medical device license application. Then we work closely with regulatory officials and our clients to help win successful approval.

Some of our clients are small companies. Draco supports some of them by acting as surrogate managers of their entire regulatory affairs and/or quality assurance operations, and supports others with less-comprehensive supporting services and consulting, as needed by the client.

• We prepare government submissions and draw on our decades of experience working with government officials to help shepherd them through the approval process.
• We design compliant procedures and systems for manufacturing facilities, warehousing, and record-keeping, including expert integration with existing information systems or design and development of new systems.
• We help implement required QA and GMP systems, including training the manufacturing, warehousing and supervisory staff to use the systems and follow GMP guidelines.
• We keep executive management advised of RA and QA activities to ensure cohesive operations.
• If the client requires it we
  • manage record-keeping and document control,
  • properly handle complaints,
  • inspect and release products,
  • act as the primary contact with government, and
  • are on-site for government audits/inspections and follow-up.
• We provide some or all of these services, depending on our clients' needs for regulatory compliance and quality excellence.

Some of our clients are large companies, including some of the largest in the world, often with facilities and suppliers scattered around the globe.

Draco typically supports these clients by taking on outsourced projects which exceed the company's current staff capabilities. The outsourced projects may be

• new drug submissions, medical device license applications, clinical trial applications, natural health product applications, DIN registrations, or other regulatory affairs services or quality assurance services,
• ensuring the GMP compliance of company or supplier facilities, so on-site inspections and audits of facilities in Canada and around the world, with government inspectors or as pre-inspection assessments and surveillance audits, are among our services.
• consulting on labelling, packaging, product monographs, SOP's, and other support services or consulting.

Extraordinarily experienced    Efficient and cost-effective

Flexible and innovative    Friendly and approachable

Dedicated to continuous improvement