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


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) Format.

Prepare and/or reviews the following formats:
• Investigational New Drug Applications (IND/IMPD)
• New Drug Marketing Applications (NDS/MAA/NDS)
• Abbreviated New Drug Applications (ANDA)
• IND/NDA/ANDA/NDS Amendments, Supplemental New Drug Applications (sNDA), IMPD Substantial Amendments, 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
• Appendices
• Regional Information

Provides documents as:
• WORD files
• PDF files
• Hypertext linking available

REGULATORY AGENCY INTERACTION
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
• Pre-IND, End-of-Phase 2 and Pre-NDA/MAA meetings including strategic planning, meeting requests/pre-meeting briefing packages, presentation.
• 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 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.