CMC Consulting Services

Bernstein CMC Regulatory Consulting provides comprehensive regulatory compliance and Pharmaceutical Sciences development services to the pharmaceutical and biotech industry. We provide a full range of coordinated regulatory and technical services including:

Regulatory Submissions

• Draft, write, review and/or compile CMC sections of IND, NDA, CTA, ANDA, DMF, CTD and other marketing applications
• Write CMC sections of pre-IND, EOP2 and pre-NDA technical packages for meetings with FDA or other regulatory agencies
• Write the P2 Pharmaceutical Development section of NDA applications

Regulatory Activities

• Interpretation of FDA and international regulations and guidelines
• Represent company at FDA or other regulatory agency meetings
• Maintain Quality Assurance responsibilities for virtual companies (e.g., batch record review, release of clinical supplies)

Scientific Management of CMC Development Programs

• API (Active Pharmaceutical Ingredient) research and development
• Analytical chemistry; assays and specifications, stability studies
• Formulation of dosage forms (solid oral, injectable, topical, inhalation, drug-device combinations) and pre-formulation studies to support effective formulation development
• Manufacturing and packaging of clinical trial materials
• Scale up and commercialization

Development Plans

• Define the CMC pathway forward as a prelude to Request for Proposals from CMC contractors
• Define CMC requirements based on toxicology and clinical requirements
• Provide development plans suitable for inclusion in investor meetings or proposals
• Write development reports for inclusion in regulatory submissions

GMP Compliance Assessments and Audits

• Due diligence audits of prospective CMC contractors (qualification audits)
• GMP compliance assessments (of your organization or of CMC contractors)
• Mock FDA Pre Approval Inspections
• SOP and Documentation assessments

CMC Contractor Selection and Management

• Identification, selection and oversight of CMC contractors
• Define appropriate work and evaluate Request for Proposal
• Monitor contractor progress according to project timelines and milestones
• Act as scientific liaison with CMC contractors (API, formulation, manufacturing, analytical, clinical trial material packaging, assembly and distribution)
• Man-in-the-Plant for critical CMC operations
• Maintain a Quality Assurance role for virtual organizations

Clinical Trial Material

• Develop packaging and labeling protocols consistent with clinical requirements
• Man-in-the-Plant oversight
• Review and approve CTM batch records and GMP documentation
• Release clinical supplies for shipment to clinical sites

In-house Customized Training and Educational Programs

• The Investigational Drug Supply Process
• Linking Good Science with Regulatory Compliance for IND projects
• Essential CTM (Clinical Trial Materials) for Clinical Research professionals
• GMPs for Clinical Supplies

Developing Internal Infrastructure

• Drafting SOPs for emerging pharmaceutical and biotech organizations
• Transfer of CMC knowledge and responsibilities to newly hired professionals
• Facility design
• Review architect and building contractor plans for GMP facility

Best Attainable Practice Assessments (BAPA)

• Fresh-eyes evaluation of current activities and operations for CTM and CMC activities
• Interactive meetings with staff to define best practices forward
• Comprehensive analysis of current practices and written suggestions for improvement