1. STRATEGIC LEADERSHIP
Stage-Gated Development Strategy
Building Phase-Appropriate CMC Strategies from Discovery to Commercialization
We help biotechnology companies
- Build phase-appropriate CMC strategies
- Reduce technical and regulatory risk
- Integrate developability with CMC planning
- Accelerate IND/IMPD readiness
- Prepare robust clinical and commercial manufacturing
Development stages
- Discovery and in silico analysis
- Developability
- CMC: Process Development, Formulation & Manufacturing
- IND/IMPD Regulatory Filing
Fractional Head of Quality
Provide executive-level Quality leadership on a full-time, part-time, or project basis.
- Quality strategy & leadership
- Batch record review & release
- CAPA & risk management
- Vendor quality oversight
- Team mentoring & development
FRACTIONAL VP OF CMC
Strategic CMC Leadership When You Need It Most
Provide executive leadership to accelerate development, reduce technical risk, and guide CMC, Quality, Regulatory, and manufacturing activities from early development through commercialization.
- Executive CMC strategy
- Cross-functional leadership
- Sponsor-side CDMO oversight
- Technology transfer
- Regulatory & Quality strategy
- Risk management
- Executive advisory
DEVELOPMENT PROGRAM FINANCIAL STRATEGY
Financial Planning to Support Smarter Development Decisions
Support executive teams with financial planning, forecasting, and portfolio analysis to align development strategy with business objectives. Integrate technical, operational, and financial planning throughout the product development lifecycle.
- Development program budgeting
- CMC cost forecasting
- Clinical program financial planning
- Portfolio and scenario analysis
- CDMO budget evaluation
- Capital planning and resource allocation
- Executive financial reporting
- Cross-functional business support
2. CMC DEVELOPMENT
ANALYTICAL & BIOANALYTICAL DEVELOPMENT
Develop analytical strategies that support robust product characterization, process development, clinical manufacturing, and regulatory submissions while providing technical oversight of analytical and bioanalytical activities performed by specialized laboratories.
- Analytical strategy and CMC planning
- Product characterization
- Method lifecycle management
- Method qualification and validation strategy
- Stability and specification strategy
- Bioanalytical assay planning
- CRO oversight and technical governance
- Data interpretation and regulatory support
DRUG SUBSTANCE & PROCESS DEVELOPMENT
Provide technical leadership for scalable manufacturing processes from laboratory development through GMP production.
- Process development and optimization
- Upstream and downstream process development
- Synthetic route development (small molecules)
- Process characterization and robustness studies
- Design of Experiments (DoE) and process optimization
- Scale-up and technology transfer
- GMP process development and manufacturing support
- Process validation strategy and lifecycle management
Formulation development strategy
Strategic formulation leadership supporting successful clinical and commercial products.
- Preformulation strategy
- Injectable formulations
- Oral dosage forms
- Topical & transdermal products
- Ophthalmic formulations
- Pulmonary & inhalation products
- Liquid & lyophilized formulations
- Controlled-release technologies
- Advanced drug delivery systems
- Drug-device combination products
- Stability optimization
3. QUALITY AND REGULATORY
Regulatory CMC Strategy & Submissions
Develop comprehensive CMC strategies and documentation to support global regulatory submissions from early development through commercialization.
- IND & IMPD submissions
- NDA, BLA & MAA support
- Module 3 (CMC) authoring
- Regulatory due diligence
- Health authority interactions
QMS Development & Implementation
Design and implement scalable Quality Management Systems aligned with FDA, EMA, and ICH expectations.
- QMS design (cGMP/GxP)
- SOPs, policies & quality manuals
- Document control & training
- Change control & CAPA systems
- Inspection readiness
GMP & Quality Audits
Conduct sponsor-side GMP audits of domestic and international CDMOs.
- GMP & Quality System audits
- Process & facility evaluations
- Data integrity assessments
- Audit reports & CAPA follow-up
- Ongoing quality oversight
CDMO EVALUATION & SELECTION
Identify, qualify, and manage the right development and manufacturing partners.
- Technical due diligence
- Capability & capacity assessment
- Quality system evaluation
- Risk-based vendor qualification
- Quality & Technical Agreements
AI Applications in CMC & Quality
Leverage specialized AI solutions to accelerate pharmaceutical development while maintaining scientific and regulatory rigor.
- AI-assisted CMC documentation
- QMS development & document management
- Technical review & gap analysis
- CDMO evaluation & due diligence
- Custom AI agents for CMC & Quality
Ready to Accelerate Your Development Program?
Schedule a complimentary consultation to discuss your CMC, Quality, Regulatory, or CDMO strategy.
email: vadim@keypharma.com
Tel#: 1 (858) 858-281-9710
