Alba Biologics Group

By: Alba Biologics Group  09-12-2011
Keywords: Strategic Planning, Due Diligence, Technology Transfer

Alba Biologics GroupпїЅs 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

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

Keywords: Drug Development, Due Diligence, failure analysis, Process Optimization, Strategic Planning, Technology Transfer

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