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Consulting Services

Facility Design Manufacturing Quality Audit Training Due Diligence FDA / CMC

     

Our firm provides a number of consulting services, which are described in detail under the WebPages shown above.  A short description of each is listed below:

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Facility Design Services - Our firm has completed conceptual facility design plans for 40 manufacturing facilities, including 30 facilities for cell and gene therapy products.  We work with our clients to define their specific needs and to provide a facility design optimized for those needs that also meets FDA cGMP/QSR/GTP requirements, as appropriate.

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Manufacturing Services - Assistance is provided for research, development, scale-up, and clinical and commercial stages of production.  Technology analysis/evaluation, production problem-solving and regulatory compliance programs are included.

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Quality Services - Support is provided for the development of quality systems and for assessment/oversight of pre-clinical, clinical and commercial manufacturing, as required for regulatory compliance.

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Audit Services - We conduct vendor audits, contract manufacturer and testing laboratory audits and provide development assistance/assessment for internal audit programs.

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Training Services - cGMPs, GTPs, QSRs and GLPs require annual training on the specific regulations for all manufacturing/testing employees, as well as job-specific training on operational procedures and document systems.  Introductory and annual training on the appropriate regulations are provided in sessions tailored to each client's specific needs.  Development and assessment of job-specific training programs may also be furnished.

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Due Diligence Services - Interactions between various organizations that involve mergers, acquisitions, significant investments, technology transfers, transfer of product assets or intellectual property, etc. generally require assessment by outside experts to ensure compliance with the acquiring company's fiduciary responsibilities.  Our firm provides this expertise in manufacturing, quality and manufacturing associated regulatory areas.

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FDA / CMC Services - Interactions with the FDA and submission of marketing applications generally fall under the purview of the Regulatory Affairs department in most organizations.  Our firm provides expertise for those regulatory areas that involve manufacturing and/or technology issues.  We participate in FDA meetings where these issues are discussed.  We generally take the lead role during FDA facility related meetings, when our facility design is reviewed by the agency.

In addition we prepare and/or review CMC (Chemistry, Manufacturing and Control) sections of IND, IDE, BLA, NDA, and PMA documents and their amendments for submission to the FDA.

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