Lewis

    CMC

        Consulting, Inc.

Lewis CMC Consulting provides quality Chemistry, Manufacturing, and Controls (CMC) regulatory consulting services including strategic planning; development, preparation, and review of CMC sections; regulatory agency interactions; training; and coordination of other regulatory activities.

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SERVICES

Lewis CMC Consulting provides the expertise necessary to deliver quality Chemistry, Manufacturing, and Controls regulatory dossiers that expedite product approvals.

  Regulatory strategy consultation and planning

  Development, preparation, and review of CMC documentation

  Regulatory agency interactions

  Template and regulatory guide preparation for submissions and technical documents

  Coordination activities

  Training

CLICK HERE FOR DETAIL OF SERVICES

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CREDENTIALS

Beverly G. Lewis, RAC - Principal

  Regulatory Affairs Certified (RAC)

  over 25 years pharmaceutical experience

  over 19 years experience in CMC Regulatory Affairs

  Successful preparation and/or review of:

• Original Investigational Applications

• Original Marketing Applications

• Amendments, Supplements, and Variations for pending and approved dossiers

• Letter Responses

• Annual Reports

  Member: Regulatory Affairs Professional Society, Parenteral Drug Association, American Chemical Society, American Association of Pharmaceutical Scientists

  Acted as instructor for Pharmaceutical Training Institute (PTI)— "Complying with Chemistry Manufacturing and Controls Requirements"

  PUBLICATIONS

• Lewis, Beverly.  2002.  "Outsourcing CMC Regulatory Affairs Services."  Contract Pharma (Volume 4  Number 4):  72-84.

• Renn, Mike, Karen Hall, Dennie Harris, Beverly Lewis, and Adriawa Evans.  2000.  "How Outsourcing Providers Can Meet Challenges and Opportunities."  Pharmaceutical Technology Contract Services (August).

• Lewis, Beverly, Mike Renn, and Ken Manning.  2000.  "CMC Section Development:  An Integral Part of the Regulatory Process."  Innovations in Pharmaceutical Technology (Volume 00  Issue 6):  125-128.

  PRESENTATIONS

• "Differentiating CMC Requirements for Phases I through III,"  Chemistry Manufacturing and Controls, 2004 Conference sponsored by the Institute of International Research, July 2004

• "Analytical Methods Validation Through Drug Development, Registration, and Marketing," Chemistry, Manufacturing, and Controls Conference sponsored by Barnett International, January 2003.

• "Successful Contract CMC Dossier Preparation," Chemistry, Manufacturing, and Controls Conference sponsored by Barnett International, January 2001.

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CONTACT INFORMATION

Lewis CMC Consulting, Inc.

Mailing Address:     P.O. Box 907, Nags Head, NC  27959

Office Phone:           1.843.664.0933

Fax Number:            1.843.664.0961

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