Our Experise
Strategic Consulting
We assist biotech companies in developing and implementing Phase-dependent Strategies and project plans and help optimize their research, development, and commercialization efforts. Our strategic consulting services cover market analysis, portfolio optimization, partnership strategies, and competitive intelligence
Technical Expertise in Bio/Pharmaceutical Process and Product Development
- Analytical Development, Qualification and Validation
- Pre-Formulation and Formulation
- Advanced Drug Delivery Systems and Drug Device Combinations
- Technologies for High Throughput Screening (HTS)
- Design of Experiments (DoE), and Statistical Evaluation
- Aseptic/GMP Process Development
- Module 3 (CMC Sections) for Regulatory Filing
- Development of Quality Systems
- Cleaning Validation and Environmental Safety Evaluations
- Process Economics
Program Management and Technical Operations
Our Operations Consulting services help Key Pharma's clients to optimize their operations and increase efficiency. We work with you to identify areas of improvement, streamline processes, and help you run your business more effectively.
- Project/Program Management from Early to Late Stage Drug Development
Criteria selection for Project Portfolio Development - Scoring Systems and KPIs for Portfolio Performance Measurement
- Selection and Management of CROs/CMOs/CDMOs in the USA, EU, India and China
- Project Management for International Tech-Transfer
Development of Quality Management Systems (QMS)
- Quality Management
- Design Control
- Training Management
- Requirements Management
- Supplier Qualification
- Product record control
Bio-Analytical Development and Validation
- Digital and Quantitative PCR
- MicroAlert assay
- ELISA
- Cell-based assay
- Western blot
- Immunoblot
Regulatory Affairs
Our regulatory affairs experts navigate the complex landscape of regulatory requirements to ensure compliance and expedite product approvals. We provide guidance on regulatory strategy, submissions, and interactions with regulatory agencies. Comprehensive support and management of regulatory submissions to global health authorities, including the FDA, EMA, and others; Support for Briefing book packages; Module drafting; Expert guidance on regulatory strategy, submission planning, and documentation preparation to facilitate timely approvals; Oversight of regulatory compliance throughout the development process to mitigate risks and ensure successful market entry.
GMP/Quality Audit of CDMOs
- Quality Management System (QMS),
- General controls
- Facility control
- Equipment control
- Material and componet control
- Organizational chart
- Personnel training
- Operational control
- Final Drug Product control
- Regulatory compliance
Strategy and Innovation Management
- Innovation and Technology Development Management
- Creation of Roadmaps Connecting Innovative Technologies with Product Development
- Development of Alliance and Partnership Frameworks, Selection of Primary Candidates among Universities, National Labs and Commercial Companies
- Market Analysis and Research for Therapeutic Indications, NCEs, Equipment and Reagents
- Early Stage Due Diligence and Project Valuation for Innovative Drug Candidates
Financial Planning and Analysis
Key Pharma's clients can benefit from our Financial Planning Consulting services, which help develop effective budgeting, forecasting, and financial planning strategies. We work with you to create a tailored financial plan that helps you achieve your business goals from early R&D stages, during GMP manufacturing and clinical trials.'
- Strategic Financial Planning
- Financial Modeling and Analysis
- Budgeting, Forecasting, and Reporting
- Business Partnership and Cross-Functional Collaboration
- Accounting Support
- Vendor Contracting