Services

 

 

„With our expertise, network and project management skills we efficiently manage the tedious CDMO selection process for you, so that you can focus on your core competencies.“

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CDMO Partner Selection for Process Development & GMP Manufacturing

 
CMO Partner Selection
 

From pre-screening and request for proposal setup to contract negotiation – Engelbrecht Biotech Consulting will manage the complete CDMO selection process for you:

  • Tailored Request For Proposal (RFP) writing services 
  • Proposal collection from selected CDMOs including review cycles
  • Technical / GxP qualification and proposals comparison 
  • GMP audit services and support of technical discussion
  • Driving technical discussions with the CDMO team 
  • Facilitating your decision process and CDMO partner selection
  • Proposal and service agreement negotiation
  • Handover to client project management team or continue with CMC project management and operational execution of project

Engelbrecht Biotech Consulting onboards you on a journey with the right CDMO fulfilling your CMC project requirements and making it a long-term fit with your company’s mindset. 

And after selecting the right CDMO partner and signing the agreements you decide whether or not we should stay on board to continue with CMC project management and CDMO alliance management. 

 

 

„We are highly motivated to facilitate your project, support with problem solving and do our best to maintain productive collaborations and good business relationships.“ 

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CMC Project Management and Alliance Management

Engelbrecht Biotech Consulting supports you in managing your external collaborations and project execution at your CDMO partners:

  • Professional project planning and execution
  • We drive the daily business and interaction with your existing or newly selected CDMOs and external service providers  
  • Identify project risks and solve project issues efficiently
  • Maintain program oversight and healthy business relationships at your collaboration partners
  • Facilitate well-organised project teams and good working atmosphere

Engelbrecht Consulting makes sure that your outsourcing partners meet agreed timelines, budgets and product quality, allowing you to achieve your milestones and timely commencement of your clinical trials.

 

 

  

Business Development & Licensing Support

You have an exciting product or technology, need a new go-to market or in-market strategy to boost your sales and client base? 

Engelbrecht Biotech Consulting can help you with tailored expertise in Business Development and network in the Biotech and CDMO industry. We provide hands-on support in the following areas:

  • Business development strategy and execution
  • Improvement of sales processes 
  • Licensing and marketing strategy development
  • Identify and establish suitable collaboration partners
  • Negotiation of collaboration and licensing agreements.

If you would like to discuss a possible collaboration or request a quote, please contact us.

 

 

  

Interim Management

You urgently need an interim COO, Head of Program Management or replace a key member in your company? Or your company is going through a strategic change or transformation process? You are concerned that your CMC project is at risk or the CDMO team is not delivering? We can help out and get it back on track.

Engelbrecht Biotech Consulting can support you with ad-hoc interim management and leadership tasks. We love to accompany you and your company through difficult situations and company transformation processes. It motivates us to improve internal processes, working culture, collaborations and make a business more efficient and successful.

Please contact us and let us discuss a tailored solution for your situation.