We help biotech and advanced therapy teams take a process from development to commercial supply, and prepare the records, people and sites to defend it in front of regulators, partners and courts.
Every engagement is led by a senior practitioner who has run the process, not just reviewed it.
We build the chemistry, manufacturing and controls story that reviewers want to read: a defined process, justified specifications and a control strategy that matches the risk.
Independent technical opinion on manufacturing quality, GMP compliance and process failures. Reports are written to be understood by a judge or tribunal, and withstand cross-examination.
We plan and run transfers so that the receiving site reproduces your product, not an approximation of it. That means clear process knowledge, realistic timelines and agreed acceptance criteria before the first batch.
We audit you the way a regulator would, then close the gaps with you. Teams are coached on how to present their systems clearly and honestly, in the room and in the back room.
Hands-on support to keep supply on schedule while the process matures: batch record design, deviation management, process validation and the quality systems that carry a product from clinic to market.
Autologous, allogeneic, viral vector or non-viral, small changes in manufacture shift potency and safety. We work with teams who need CMC rigour without losing speed.
Short, scoped, and written down. You always know what we are doing, why, and what it will produce.
Thirty minutes, no charge. We tell you honestly whether we are the right team.
A one to two week review of your documents, data and risks, ending in a ranked action list.
We embed with your team or work independently. Weekly written status, no surprises.
Everything is documented so your team can run without us. We stay on call if you want us to.
Small teams preparing a first IND or moving into pivotal supply without a full CMC function.
Programme leads who need senior capacity for a transfer, inspection or filing.
Operations and quality leaders preparing to host a client audit or a regulator.
Counsel and funds who need an independent technical view they can rely on.
Founder and Principal Consultant
Dr. Rau is an expert in Bio processing and a Six Sigma Master Black Belt. Her international technical and managerial experience extends from development to post-commercial cGMP manufacturing.
Tiffany has also been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges. Dr. Rau has been the advisor on over 100 different projects in the areas of process intensification, scale-up, variability reduction, and continuous improvement for both mammalian and microbial expression systems.
Automation and CSA
Martin brings 30+ years of international Automation (Software Development) and Computer Software Assurance (CSA) expertise in the electronics and pharma industries.
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Rau Consulting LLC, West Laffeyette, USA