Strategic Consultancy (From development to commercial manufacturing)

Respiratory combination (pharmaceutical drug & medical device) ‘in-house’ and ‘out-source’ industrialisation strategies to move programs from development, through scale up, pivotal clinical trials supplies and ultimately commercial finished dosage form.

Combination respiratory product Industrialisation strategies require:

  • Common thinking in respect of device, product and process technologies, often linking 2 or 3 contract organisations
  • Integration with regulatory & clinical strategies.
  • Industrialisation and ultimate finished product pricing models & agreements.
  • Governed by legally binding inter-company agreements.

Due Diligence

Search/selection and full spectrum operational due diligence of pharmaceutical, medical device, active pharmaceutical ingredient (API) & excipient and original equipment manufacturer (OEM) companies.

Assessment of suitability for merger and/or acquisition or selection for request for proposal (RFP) process.

Legally binding governance documents

Supply, negotiate and execute legally binding documents to provide governance and framework to industrialisation strategies:

  • Request for Proposal (RFP)
  • Binding Letter of Intent (LOI) & Heads of Terms
  • Industrialisation & scale-up agreements including Intellectual property (IP) protection clauses and pricing (IA)
  • Quality Statements (QS)
  • Full Supply Agreements (SA)
  • Warehouse & distribution agreements (WDA)

Ethical Pharmaceutical/BioPharmaceutical Project Management

We aim to engage in the project at the conceptual stage and would deliver the project in conjunction with the client.

Our services include:

  • Day to day management of the project with a dedicated project manager from project initiation to project close out.
    • Management of multi-disciplinary and cross company project teams
    • Primary interface with customer regarding project activities
  • Project Planning
    • Integrated project plans for resourcing, scheduling, timelines and milestone tracking
    • Risk, issue and actions logs
    • Change control
    • Meeting agenda/minutes
  • Financial tracking
    • Activity costing
    • Budget management and change control
  • Communication
    • Communication plans/charters for key stakeholders
    • Project status reporting
    • Conduct project team meetings
    • Attendance at status and governance reporting meetings