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.
DEVELOPMENT, PREPARATION, AND REVIEW OF CMC DOCUMENTATION

Lewis CMC Consulting prepares CMC documentation using Common Technical Document (CTD) Format.
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:
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: TRAINING
Lewis CMC Consulting provides training on: