Consultancy Services
Whatever phase of development your project is in, there are complex decisions to be made. Jeff can help you with the individual parts of your plan as well as ensuring that the plan comes together into a well structured whole which can be delivered. Here are some of the areas of expertise:
- Salt & Polymorph Selection
- Particle Sizing & Morphology
- Analytical Methods Design, Development, Validation & Transfer
- Specification Setting
- Support for Drug Delivery Options
- Planning a Biopharmaceutics Strategy
- Interpretation and Compliance with ICH Quality Guidelines
- Writing CMC sections for Regulatory Documentation
- Preparing for Regulatory Review & Inspection
- Transferring processes from R&D to Manufacturing
- Portfolio Integration during M&A activities
In addition to supporting various pieces of your development plan - Jeff can look at existing plans for areas of risk and design strategies to mitigate that risk. He can help you deliver the plan through partnerships with other providers. In particular:
- Finding a Business (Co-Licensing/Co-Development) Partner
- Choosing an Outsourcing Partner
- Developing Low Cost Outsourcing Options in lower cost territories
- Developing the Relationship with your Outsourcing Partner
- Ensuring Quality & Delivery
These are just a few areas where Grove Lodge Consulting can help. See if we can help you develop your project.
