Biologics CMC and regulatory, from cell line to IND.

HSR Bio helps developers, CDMOs and regulatory partners take protein therapeutics into the clinic. Each engagement is a defined package with a fixed price agreed before work begins.

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Services

Packages can stand alone or run in sequence, from the first CDMO conversation to FDA submission.

CMC strategy and CDMO selection

A phase-appropriate CMC plan for your molecule, and a structured comparison of candidate CDMOs.

CDMO SOW review

A written review of technical scope, deliverables and regulatory adequacy before you sign.

IND readiness and CMC gap assessment

A prioritized gap report across cell line and MCB, process, release testing, stability, potency and comparability.

Module 2.3 and Module 3 authoring

Quality Overall Summary and drug substance and drug product sections, written to FDA and ICH expectations.

CMC amendments, IR responses and annual reports

Support for active INDs, including amendments for manufacturing changes.

DMF packages for ancillary material suppliers

Drug Master File preparation and filing strategy for suppliers to biologics and cell and gene therapy manufacturers.

eCTD publishing and submission

Fast-turnaround publishing, validation and transmission through the FDA Electronic Submissions Gateway.

Publishing training

Hands-on training so your team can build and publish its own eCTD sequences.

How we work

We work with biologics developers preparing their first IND, sponsors with active INDs, CDMOs that want regulatory-ready documentation for their clients, and regulatory firms that need a biologics CMC specialist.

Modalities: monoclonal and bispecific antibodies, antibody–drug conjugates, fusion proteins, nanobodies and biosimilars.

Our work is sized to the phase of your program, priced up front, and done under NDA. Where you prefer, we work inside your own systems, so your documents stay under your control.

Contact

Tell us about your molecule, its stage and what you need next. We will reply with a proposed package, scope and fixed price.