Senior CMC Regulatory Expertise, Built Into Your Team

Auctoria Regulatory provides senior CMC regulatory support to pharmaceutical and biotechnology companies, from first-in-human through post-approval lifecycle management. We develop CMC regulatory strategy, author and review Module 2 and Module 3 content, prepare for and manage Health Authority interactions, and support the post-approval changes that keep commercial products compliant.

The work is hands-on. The senior expert who scopes your project stays with it through delivery.

How We Work

Deep CMC expertise is where we start. What makes it valuable is how quickly it becomes part of your team.

A regulatory partner either makes a project faster or slower, and an already-stretched team either trusts them or ends up managing them. The difference comes down to reading a program's actual state, not just its documentation. It means knowing which questions need answers now and which can wait. It means contributing without a ramp-up period the timeline doesn't have and fitting into how your team already works rather than asking the team to adjust.

Auctoria Regulatory exists to do CMC regulatory work at that standard: technically rigorous, and integrated into your team from day one, not week six.

Who We Work With

Emerging biotech organizations building their first CMC regulatory package, who need senior judgment without a full in-house function.

Growing companies facing a critical submission, such as an IND/CTA, NDA/BLA or MAA, that needs experienced capacity quickly.

Global pharmaceutical teams that need a seasoned CMC lead to cover a gap, take on additional sections, or represent CMC in cross-functional forums without a learning curve.

Our experience spans small molecules, biologics, and oligonucleotides and peptides across major Health Authorities (US FDA, EMA, Health Canada, UK MHRA and others).

Senior-Led by Design

Auctoria Regulatory was founded by Jessica Kokosinski, RAC, a CMC regulatory leader with more than 25 years of industry experience, including VP-level leadership of regulatory CMC teams. She has guided programs from IND through approval and lifecycle management, and she remains directly involved in the work.