Alba Biologics Group’s extensive experience in opportunity evaluation and strategic planning 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 brings unique experience in the areas of both biosimilar drugs and therapeutic countermeasures to bioterrorism to complement expertise in traditional biological drug development.

Biosimilar Drug Development

  • 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

Process Implementation

  • Clinical Trial Product Process Development
  • Commercial Scale Process Development
  • Specification and Characterization Planning
  • Process Optimization Analysis
  • Process Failure Analysis

Biodefense Drug Development

  • Strategic Evaluation
  • Team Member identification
  • Teaming Relationship Management
  • Proposal Preparation
  • Reporting

Operational

  • Process Development Planning
  • Schedule Development
  • Process Implementation
  • Negotiating Contract Research Support
  • Project Management

Contract Manufacturing Support

  • Prepare Requests For Proposals
  • Evaluate Manufacturing Organizations
  • Due Diligence Inspection
  • Manage Technology Transfer
  • Manage Manufacturing Projects
2008 © Copyright Alba Biologics Group.
About Services Our Team Publications Contact