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Schell Associates
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Consulting services including regulatory affairs, preclinical and GLP testing, manufacturing, quality, compliance, and clinical studies.
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Bryn Mawr Partners
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Systems integration and delivery specialists for regulatory compliant quality management applications including CAPA, complaint, electronic submission, and document management systems.
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Marion Weinreb and Associates, Inc.
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Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
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Validation and cGMP Compliance
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Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters.
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