The Tamarack Group

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Description

Even the most visionary organizations seek advice. The collaborative and innovative approach of The Tamarack Group consultants benefits medical product developers and manufacturers, and those who provide services or materials to the medical product industry.

Carol DeSain's consulting services focus on regulatory compliance for biologic, biotech, pharmaceutical, diagnostic, and combination products. She has worked in the industry for more than 25 years, with start-ups, global corporations, contract manufacturers, and allied industries in the U.S. and Europe. Carol helps her clients with CTD and DMF submissions, establishing new GMP/QSR systems, re-working failing systems, establishing policy for global corporations and training management and staff.

When developing new systems or improving old ones, medical product companies and those allied with the medical product industry often ask us for example documents. On this web page for a nominal charge we provide examples of Quality Manuals, procedures, and forms frequently requested by our clients. From time to time we will remove some examples and add others.

The Tamarack Group was established to offer our unique combination of scientific knowledge and industry insight to help you maintain compliance and compete in today's complex global markets.

FDA Regulatory Submissions, Regulatory Compliance Consultants, Quality System, Training, Documentation The Tamarack Group ( Carol DeSain ) offers Regulatory, Quality System/GMP Compliance, and Quality Assurance consulting for product and process developers and manufacturers of pharmaceutical, device, diagnostic, biologic and bio-pharmaceutical medical products who distribute their products in markets regulated by the US FDA , the European Commission , and other international regulatory agencies.

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