Drug Development Challenges
Solved critical drug development challenges by improving the solubility of a large complex product, ...
Read moreWhat we can do for you!
Over 100 combined years of biopharmaceutical development experience in one family. Put our know-how to work for you.
We will work with you to fully understand your business and put together an effective plan that maximizes results.
Operations
Recombinant protein and DNA process research, development and cGMP production; problem solving/root cause analysis/process efficacy
Regulatory
CMC/IND preparations and review – CMO on site and paper audits – FDA meeting preparation & attendance
Business Development
We can offer a US base/office/representation for European or Asian organizations attempting to increase business in the US
Clinical
Clinical outsourcing and procurement contracting for Pre-clinical toxicology, PK and PD, Phase I-II and Phase III-IV projects
Six reasons to work with us
Biopharmaceutical development should not be a black box in your organization. We make sense of complex regulations and industry practices. Contact us to find out how.
We can anticipate your development issues because we likely have encountered and resolved them ourselves
We will stick by our recommendations and follow them through to complete implementation
We will tell you what you need to hear, not what you want/would like to hear and provide an accurate assessment of your development status
Our experiences have taken us round the world, with business conducted in North America, Europe and Asia
We’re a family passionate about solving world health issues and ensuring safe and effective drugs are developmented in a timely manner
Whether you need business development, product development or clinical development, you have to speak the language
Hebel Consulting
We create a unique process for each client to ensure that business objectives are met and success is achieved!!
Latest Projects
We believe in beginning projects with the end in mind. Setting goals and measuring results is only way to ensure success is achieved.
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Critical Quality Control Assay Development Solutions
Overcame previous quality control problems by leading the development of a mass spectrometry based m...
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Process Scale-up Success
Successful transition of protein manufacturing and formulation technology from academic bench-top pr...
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CMO Selection with a Specific Purpose
CMO selection, contract negotiation, vendor audit & qualification based on client specific unique ne...
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GMP Facility Design & Construction
Designed and specified a multi-product pilot cGMP manufacturing facility.
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Head of Quality
Acting Head of Quality for a virtual product development organization, allowing them to remain nimbl...
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Business Development
US business development office for an emerging biotechnology company in Asia seeking US partnerships...
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Process Improvement
Increased yield 4 fold in three months for a platform manufacturing process.
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Meet The Team
Craig Hebel
Principal
Experienced head of operations holding the position for several GMP biologics manufacturing firms (Lonza Viral Based Therapeutics, Vivante GMP Solutions, Introgen Therapeutics…). Responsible for manufacturing process development for several drugs including viral based and antibody based biologics through pre-clinical and clinical testing and finally on to commercial production.
Our services are delivered by professionals who understand your industry and market.
Skills & Services
Operations, Regulatory, Business Development …
Hebel Consulting has decades of experience in all aspects of biotech and pharmaceutical development, and operations, allowing us to assist clients identify opportunities to increase revenue, improve efficiency, and reduce costs throughout the entire product development cycle..
- Recombinant protein and DNA process research, development and cGMP production; problem solving/root cause analysis/process efficacy improvement
- Formulation development/scale up (peptides, lipids, polymers, medical devices)
- CMO contract negotiations/agreement review/project management/onsite supervision
- CRO project coordination, ensuring supplies and projected preclinical studies are carried out
- cGMP Facility specification/design/construction supervision
- cGMP Facility qualification/validation
Biopharmaceutical development should not be a black box in your organization. We make sense of complex regulations and industry practices.
Working with federal regulatory agencies such as the on specific issues affecting your business, we will ensure that your activities comply with all of the regulations and laws pertaining to biopharmaceutical product development (GMP, Sarbanes-Oxley, OSHA, etc)
- CMC/IND preparations and review
- FDA meeting attendance as product development representative for small organizations
- CMO on site and paper audits
- Regulatory for veterinary products with US FDA CVM or USDA
Strategy, negotiation, valuation, deal-making, term-sheet, contract phase, close – that’s our vocabulary
- We can offer a US base/office/representation for European or Asian organizations attempting to increase business in the US or file for US approval
- Merger/acquisition product development technology valuation
- Manufacturing alliances
- Competitive analysis
- Draft or review of business plans
- IP review
Setting your business apart from the rest
We understand not only the demographics, but also the more important psychographics of your market. Scientists are by nature skeptics. How will you persuade them?
- Online presence creation
- Search Engine Optimization
- Google Adwords account administration
- Creative design and development
- Public relations/press releases
Operations92%
Regulatory73%
Business Development85%
Marketing & PR76%
Select Clients
