Regulatory Solutions

CMC - Chemistry Manufacturing and Control Support

Our mission is to help higher management of Pharmaceutical and Biotech firms to know the level of CMC Compliance or lack thereof, and build structures and Systems that have a built-in Sustained compliance and Controls.

We specialize in providing Strategic assessment of regulatory submission documents, through targeted audits of the INDAs, NDAs, ANDAs, BLAs, and other records verifying submissions commitments and compliance.

We help higher management develop and implement Strctures and Controls with a build-in Sustained Compliance that do not choke off innovation, faster approvals of regulatory submission documents, ability to get products faster on to the market or interfere with smooth operation of business.

Verifying submission commitments up-front eliminates the element of surprise that has been experienced by other pharmaceutical and biotechnology companies when FDA walks through the door and ask to review regulatory submission documents.

We offer remedial resources to correct identified compliance gaps or discrepancies.

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

Specifically, Sensyo Inc. provides the following help:

Regulatory strategy consultation and planning

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

• 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.
• Support new business development and technical operations with expert analysis of new CMC technical capabilities in drug development
• Perform technical and regulatory audits, technology assessments and due diligence evaluations, and support and conduct mock pre-approval inspections of client facilities for licensing, mergers, acquisitions, investments and litigation
• Assure that product performance claims are substantiated with technical data
• Provide confident evaluation of new technologies and expert advice on technology transfer and assessments
• Offer pragmatic advice on unconventional and frontier technologies

Development, preparation, and review of CMC documentation

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

Preparation 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

Regulatory agency interactions

• Communication and negotiations with Regulatory Agencies are important for any Development Program. Sensyo Inc. has experience interacting with CMC chemistry 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.