Give your idea a map.
There is no one way to a new product idea, but many of them.
Bringing me in during brainstorming and strategic portfolio optimization meetings will enrich these discussions. My extensive experience in real operative drug product development together with my fresh perspective on your situation will generate new and perhaps unconventional ideas that will drive the process forward.
Let me take care of the conceptual work. Structured and backed by a detailed compilation of all relevant information I will smooth your path to good decisions. To address the uncertainty usually present at the early stages of this process, I perform early feasibility and well-structured, comprehensive pre-development studies. With these in hand, we’ll learn more about the molecule in question, get a “feeling” about it, foster the process of developing ideas and get a better sense of the potential challenges and risks to come. These tools minimize the risk and bring the project planning onto a more realistic and secure path.
- Idea generation for new product proposals
- Intensive, specialized research (e.g., literature, internet, patents, etc.) incl. summarizing and conclusions
- Assessment of technical feasibility, regulatory and clinical strategy
- Execution and coordination of predevelopment and feasibility studies
- Compilation and assessment of all relevant information
- Project planning for feasibility and project execution
- Compilation of development strategy
- Project management for execution (internal or external)
The bridge between API manufacturing and formulation development.
I offer project management for any of your projects, including all controlling and reporting tasks.
Based on my years of operative experience I can effectively oversee any internal and external project execution, coordinate all required activities as well as all involved parties and/or potential external contractors.
Thanks to my experience as a service provider, you can rest assured that I will find the right partners for your project, ask the right questions, assess the situation correctly – and, when necessary, present solutions to any problems which may arise. In instances where you need a trouble-shooter to point the way forward out of a difficult situation, I can assist by providing fresh ideas and perspectives.
EXTERNAL PROJECT LEAD
I will take over responsibility for your projects.
Many years of experience
With many years of experience as a CDMO and having successfully executed several customer drug product development projects, I will take over responsibility for your projects you are intending to execute with external service providers. I will support you with:
- compilation of development conception and strategy
- Search and assessment of potential service providers
- Compilation of extensive, highly professional RfQ documentation (Request for Quote)
- project planning and negotiation with short listed CDMOs
- site visits, technical Due Diligence, and technical discussions with CDMO
- monitoring during project execution
- compilation of development documentation and reports, if required
- support of tech transfer to your manufacturing site or different CMO
I have been cooperating with many CDMOs in Europe and Asia, made a lot of experience with many challenging projects and will be able to find the best way of cooperating with any CDMO on your individual project.
IMPLEMENTATION OF NEW TECHNOLOGIES
I can bring a wealth of real world experience to your project.
Let me support you with my operative hands-on experience
If you are planning to implement new technologies in the field of oral solids, I can bring a wealth of real world experience to your project. Let me support you with my operative hands-on experience in the following areas:
- extrusion/ spheronization/ pelletiziation technologies,
- multiple units
- modified release products
- compression of multiple units to tablets
- effervescent products
- orodispersible granulates
- melt coating and melt granulation
- stabilization and formulation of morphic modifications
- stabilization of sensitive and/ or hygroscopic APIs
- improvement of solubility and bioavailability
- predevelopment, phys.chem. characterization
- and many more…
Innovation is for winners.
In today’s market, the development of generic products is becoming increasingly complex and requires a long-term vision coupled with a clear strategic approach.
Global competition and price pressure have increased and with it also the number and complexity of patents and applications. Add differing jurisdictional patent and regulatory requirements, new reimbursement and distribution systems and constant pressure on prices and generics product development is more complex than ever before.
- Research and assessment of the IP and regulatory situation* (with my partners)
- Definition of project concept and planning
- Definition of product development and IP strategy
- Conception for generics with added value differentiating from the original product, depending on market – incl. regulatory and resulting clinical strategy
- API and dossier sourcing * (with my partners)
- Execution of feasibility studies and product development
- Definition and implementation of R&D strategies for generics drug product development