Benchmarking Excellence: Evaluating CDMO Capabilities for API and FD Development Outsourcing

Objective :

Assessment of various CDMO companies for outsourcing capabilities

Problem Statement:

A large pharma client was working to develop their API and FD, and was interested in assessing CDMO companies and their capabilities in this domain to provide benchmarking of the best company for outsourcing their project. The client requested a one-time report on all the contract development and manufacturing organization analysis and reports on the R&D, manufacturing, and commercializing capabilities of the companies, through Secondary and Primary CI inputs.

Our Methodology:

• Identifying CMOs
  • Conduct a thorough search and identification of potential Contract Manufacturing Organizations in geographies of interest to client.
• Secondary and Primary CI Inputs
  • Gather Competitive Intelligence (CI) from secondary sources and conduct primary research through interviews and surveys to suit client's requirements.
• Analyze Current Status and Potential Timing of the Project
  • Evaluate the current status of the project and estimate potential timelines for completion.
• Ordering Equipment
  • Determine the quantity of equipment needed.
  • Plan for delivery schedules.
  • Oversee the installation and validation processes.
• API Availability
  • Assess the availability of Active Pharmaceutical Ingredients (APIs).
• Partnership with Other API Companies
  • Identify potential API suppliers and evaluate partnership opportunities.
• Sterilization Process Details
  • Review and detail the sterilization processes involved.
• Challenges and Barriers
  • Identify and analyze potential challenges and barriers to the project.
• Plant Location
  • Evaluate the location of manufacturing plants for logistical and strategic advantages.
• Manufacturing Status
  • Assess the current manufacturing status and capabilities of identified CMOs.

Results:

• Designed a robust framework for the client’s research needs and provided detailed CDMO profiles of the companies
  This framework allowed the client to streamline their research process, offering a comprehensive understanding of potential CDMO partners. The detailed company profiles gave them clear insights into the strengths, weaknesses, and capabilities of each CDMO, enabling informed decision-making for outsourcing their project.
• Conducted a study on the R&D technology utilized, manufacturing capabilities, and commercial outlook
  The study provided the client with a deep understanding of the CDMO technological expertise and manufacturing strength of potential partners. It also evaluated the commercial potential and long-term viability of the companies, helping the client select a partner that aligned with their project goals and market aspirations.
• Performed a competitive assessment of various CDMO companies
   The competitive assessment highlighted the positioning and performance of various CDMOs in the market. This insight enabled the client to assess their options against industry benchmarks, ensuring they chose the most capable and competitive partner for their API and FD development needs.
• Provided evidence-based results to create strategic support for the client’s market entry goals
  The evidence-based insights helped the client align their strategy with market realities. By backing strategic decisions with data and analysis, the client was better equipped to navigate the regulatory and competitive landscape, ensuring a smoother market entry and long-term success.

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