Lewis CMC Consulting, Inc.

Detail of 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

Lewis CMC Consulting provides strategic, regulatory, and scientific planning from the Pre-IND phase to post-approval.

• Strategic CMC regulatory advice.

• Identification of CMC information appropriate for regulatory dossiers including determination of suitable analytical specifications, method validation evaluation parameters and minimum stability data requirements.

• Gap analysis of available CMC information.

• Evaluation of proposed manufacture and controls changes for dossier impact.

• Evaluation of CMC Regulatory capability of potential contract manufacturing facilities.

• Liaise between your Company and Contract Service Providers regarding development of information impacting product registration.

  Development, preparation, and review of CMC documentation

Lewis CMC Consulting prepares CMC documentation using Common Technical Document (CTD) or Standard IND/CTX, NDA/ANDA/MAA Formats.

Prepares and/or reviews the following dossiers:

• Investigational New Drug Applications (IND/CTX)

• New Drug Marketing Applications (NDA/MAA/NDS)

• Abbreviated New Drug Applications (ANDA)

• IND/NDA Amendments, Supplemental New Drug Applications (sNDA) and CTX/MAA Variations

• Deficiency Letter Responses

• Annual Reports

• Drug Master Files (DMF)

• GMP Statements

• Debarment Certifications

• Drug and Establishment Listing

Prepares and/or reviews the following dossier sections:

• Quality Overall Summary

• Drug Substance

• Drug Product

• Environment Assessment Categorical Exclusion

• Methods Validation

• Validation of Sterilization Process

• Field Copy

Provides documents as:

• Paper copies

• WORD files

• PDF files

• Hypertext linking available

  Regulatory agency interactions

Communication and negotiations with Regulatory Agencies are important for any Development Program.  Lewis CMC Consulting has experience interacting with CMC reviewers, including the following:

• Effective negotiations with Regulatory Authorities.

• End-of-Phase 2 and Pre-NDA/MAA meetings including strategic planning, meeting requests/pre-meeting briefing packages, and presentations.

• May interact directly with FDA as client's agent or provide support to client company on CMC related issues.

  Template and regulatory guide preparation for submissions and technical documents

Regulatory documentation must be complete and of consistent quality.

Lewis CMC Consulting will prepare customized CMC dossier and technical document templates.

In addition, customized corresponding Regulatory Guides which provide author instruction for document contents may be prepared."

  Coordination activities

Lewis CMC Consulting can act as coordinator for other regulatory activities for your company including...

• cGMP Compliance and Inspection assistance.

• Process validation.

• Preparation of electronic submissions.

• Pharmaceutical and Analytical development strategies.

• Development of regulatory training programs.

  Training

Lewis CMC Consulting provides training on...

• CMC Regulatory requirements for investigational, marketing, and post-approval submissions.

• Preparation of CMC submissions for INDs, NDAs, DMFs.

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