Alba Biologics Group�s extensive experience in new opportunity evaluation, strategic planning and biologic drug development enables its
clients to transition their products from discovery to the clinic and to commercialization faster and with less expense and risk.
Whether your product is in the research laboratory, pre-clinical development or already in clinical trials,
we can help increase its value by working with your staff or independently to plan and manage the forward progress of your drug to the commercial market.
Alba Biologics also brings unique experience in the areas of both biosimilar drugs and therapeutic
countermeasures to bioterrorism to complement expertise in traditional biological drug development.
Drug Development
- New Opportunity Evaluation
- Strategy Development
- Program Planning
- Regulatory Strategy
- Contract Management
Strategic Business Planning
- Strategic Planning and Research
- Technical Evaluation
- Process Development Planning
- Contract versus Build Evaluation
- Facilitate Strategy Planning Sessions
Contract Manufacturing Support
- Prepare Requests For Proposals
- Evaluate Manufacturing Organizations
- Due Diligence Inspection
- Manage Technology Transfer
- Manage Manufacturing Projects
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Regulatory Support
- GLP preclinical study designs / outsourcing / management
- Pre-IND / CTA submission
- IND / CTA submissions
- Management of agency meetings
- Orphan Drug eligibility evaluation / submission
Operational
- Process Development Planning
- Schedule Development
- Process Implementation
- Negotiating Contract Research Support
- Project Management
Manufacturing Process Implementation
- Clinical Trial Product Process Development
- Commercial Scale Process Development
- Specification and Characterization Planning
- Process Optimization Analysis
- Process Failure Analysis
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