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.
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
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.
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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