Drug Development Challenges
Solved critical drug development challenges by improving the solubility of a large complex product, ...
Read moreOver 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
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 create a unique process for each client to ensure that business objectives are met and success is achieved!!
We believe in beginning projects with the end in mind. Setting goals and measuring results is only way to ensure success is achieved.
Solved critical drug development challenges by improving the solubility of a large complex product, ...
Read moreOvercame previous quality control problems by leading the development of a mass spectrometry based m...
Read moreSuccessful transition of protein manufacturing and formulation technology from academic bench-top pr...
Read moreCMO selection, contract negotiation, vendor audit & qualification based on client specific unique ne...
Read moreDesigned and specified a multi-product pilot cGMP manufacturing facility.
Read moreActing Head of Quality for a virtual product development organization, allowing them to remain nimbl...
Read moreUS business development office for an emerging biotechnology company in Asia seeking US partnerships...
Read moreIncreased yield 4 fold in three months for a platform manufacturing process.
Read morePrincipal
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.
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..
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)
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?