Biotech Consulting

MAbs |Growth Factor | Hormones | Fusion Proteins | Cytokines |Therapeutic Enzymes | Recombinant Vaccines | Blood Factors | Anticoagulants, other innovator biologics, new drug delivery systems, combination products and diagnostics offer new promise to patients globally. Biosimilars | Follow-on Biologics | Biogenerics are also of great interest to manufacturers today.

PAREXEL Consulting's Biotech Consulting experts can help you develop the right innovator or follow-on product for the right patient population and with the right plan to bring it successfully to the market and keep it there.

Key Offerings: Development with Approval and Market Access in Mind

• Market Assessment
• Candidate Selection, Due Diligence, Gap Analysis
• Scientific Advice
• Regulatory Authority Advisory Services and Meeting Preparation
• Comprehensive Product Development Strategy
• Preclinical / Nonclinical Research
• Comparative Effectiveness Strategy and Clinical Research
• Development Planning: Preclinical through Launch
• Development Execution
• Product Positioning and Medical Communications
• Lifecycle Management Planning and Execution

Value Proposition

Biologics and next-stage product development requires a highly specialized cross-disciplinary team effort. We apply our fusion of expertise to help ensure your product's success through:

• Selection of viable and vetted candidates for sound investment and development efforts
• Product characterization with a well formulated regulatory pathway for approval or accelerated approval
• Expert-guided development strategies and plans that help maximize approvability and access, minimize costs and delay and help ensure product quality and safety
• Development of your company's products with approval and access in mind including comparative effectiveness and reimbursement considerations and activities
• Effective program management that helps your company meet critical milestones and target approval dates
• Seasoned expertise and knowledge of Regulatory Authorities and their thinking in regard to your product type

Contact Us

For further information and to get in touch with our experts, please  use our contact us form and type "Biotech Consulting" in the comment field so we can assign the right expertise for further discussion. Thank you!