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.
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 plans/charters for key stakeholders
- Project status reporting
- Conduct project team meetings
- Attendance at status and governance reporting meetings