CBS Logo
Scientist reviewing labeled medicine bottle on a pharmacy shelf during regulatory compliance check.

Regulatory Support for All Stages of Development



With senior regulatory experts across the US, EU, and China, Crystal Bio Solutions functions as an extension of your team. We design global regulatory strategies, author defensible documents, and manage authority interactions to keep your program inspection-ready: from IND/CTA through BLA/MAA, using ICH-aligned best practices and eCTD publishing.


Let's talk
CBS orange-blue banner-1
Regulatory Strategy End-to-end guidance across development: target product profile and gap assessments, global/bridging plans (FDA/EMA/NMPA), indication and study pathway, comparability for biologics/ADCs, and expedited designations (Fast Track, Breakthrough, RMAT, PRIME) when appropriate. Authoring & Medical Writing Clear, defensible documentation: protocols and IBs, SAPs, CSRs, nonclinical/clinical overviews (CTD Modules 2–5), patient-facing ICFs, briefing packages, and written responses aligned to ICH, GCP, and local guidance. Submission & Approval Submission operations and lifecycle: IND/CTA preparation, eCTD compilation/publishing, QC, query management, variations/supplements, and post-marketing commitments; delivered on schedule and audit-ready.
Doctor in a white coat with a stethoscope reviews a blue clipboard, pen in hand, with a white pill bottle on the desk. Relationships With Authorities We maintain active, structured communication with FDA, EMA, and NMPA on behalf of sponsors. Our team plans meeting strategy, prepares briefing packages and written responses, manages timelines and minutes, and guides query resolution so your development pathway anticipates regulator expectations from pre-IND/Scientific Advice through approval.

Highlights:

• Pre-IND/Scientific Advice strategy and questions
• Briefing books, slide decks, and meeting rehearsals
• Written responses, minutes, and follow-ups
• Ongoing query management and risk tracking Clinician adjusts an IV catheter for a seated patient wearing a headscarf in an infusion clinic. Therapeutic Expertise CBS supports complex programs across biologics, ADCs, and CGT while also covering small molecules and 505(b)(2) when needed.

Modalities & programs:

• Monoclonal and bispecific antibodies, fusion proteins, biosimilars
• ADCs (clinical experience), radiopharmaceuticals
• Cell & gene therapy programs
• Small molecules and 505(b)(2) applications

Have a Question?

Connect with our experts and get started on your project today.

Free Consultation