Our CMC Regulatory Consultants can support you during the entire development process of your product, either as a strategic partner for CMC development or with single consulting solutions throughout your program and through product life-cycle management.
We ensure that your CMC program has the requisite quality, consistency, and technical validity, while conforming to the various global regulatory requirements and quality standards.
CMC Regulatory Expertise
Allucent’s team of seasoned CMC scientists has the experience to support a diverse portfolio of product types including small molecules, biologics, biosimilars, cell and gene therapies, vaccines, and combination products in the United States, Canada, Europe, and around the globe.
We can lead your team or assist you with the CMC aspects of regulatory interactions and submissions to various global health authorities.
CMC Consulting
Our CMC A-Team provides a unique, tailored approach to your program, identifying the ideal development and manufacturing strategy that effectively manages time, quality, and cost.
We will support you in identifying third-party GMP manufacturers and suppliers for excipients and drug substances, drug product manufacturing, and recommend appropriate analytical method development and validation.
Our CMC Regulatory Strategy and Support
- Strategic direction and support for:
- Formulation evaluation
- Manufacturing and supply chain strategy
Gap and risk assessments - Data evaluation
- Due diligence and product portfolio evaluations
- Product development planning
- Lifecycle change control and maintenance, application evaluations, and submissions (CBE, PAS)
- CMC regulatory technical authoring and document review
- Health authority meetings, interactions, responses, and strategic planning
- Supply chain and manufacturing strategy
Additional Details about Our CMC Clinical, Technical, and Program Support Services
Strategic Advice
- Pharmaceutical development gap analysis
- U.S. and global pharmaceutical development plans
- Capability assessment
- Due diligence assessments and asset evaluations
Drug Product Delivery Technologies
- Oral: Tablets, capsules (including soft gel capsules), and liquids (solutions, suspensions)
- Parenteral: Injectables, lyophilized products, prefilled syringes, and radiopharmaceuticals
- Transdermal: Patches, gels, creams, and lotions
- Inhalation: Aerosols (MDI, nasal, nebulizer), dry powder (DPI) and other inhalation technologies
- Topical: Ointments, lotions, creams, and gels
- Combination products (drug/drug, drug/device, biologic/device), and medical devices/in-vitro diagnostics
Manufacturing
- Management of drug substance and drug product development
- Selection and qualification of drug substance and drug product suppliers
- Cell bank qualification and viral clearance studies
- API process development and optimization
- Formulation and dosage form development
- Quality assurance programs (quality systems and SOPs)
- Review of design and construction of manufacturing facilities to meet standards
Analytical and Quality Systems
- Oversight of Analytical Method Development and Validation, setting of appropriate specifications
- Process validation, risk management, and quality by design (QbD)
- Setting Critical Process Parameters (CPPs) and identification of Critical Quality Attributes (CQAs)
- Formal GMP/GLP quality audits
Clinical Trial Supply Management
- Management of Investigational Medicinal Product (IMP) production activities
- Selection and management of clinical supply vendors and facilities along the development cycle
- Management of IMP supply to minimize waste
- Planning and oversight of IMP packaging and labeling activities and assistance with blinding and randomization protocols
Regulatory Submission Support and Health Authority Engagement
- Preparation, authoring and/or review of global CMC regulatory submissions
- Preparation, authoring and/or review of master files (DMFs, BMFs, ASMFs, etc.)
- Strategy, guidance and authoring of submissions for post-approval change (annual reports, PAS, CBE, Type I and II variations)
- Interpreting FDA and international requirements, regulations, and guidance
- FDA interactions including responses to information requests as well as participation in Agency meetings such as pre-IND, end of Phase II, pre-NDA/BLA meetings, and type B or C meetings
- EMA scientific advice support and participation in Health Authority meetings
