Most emerging biopharma companies engage regulatory consultants for strategy and then struggle to execute it. Submissions get delayed. Agency correspondence sits unanswered for weeks. Compliance gaps surface during inspections. The science is solid — the regulatory execution is not.
Katogen Operations provides senior regulatory affairs support across the full product lifecycle — from initial pathway strategy through submission preparation, agency communications, compliance, and ongoing lifecycle management. We cover Rx small molecule, gene therapy, OTC, switch programs, and medical devices including combination products.
This is not a junior team following a checklist. These are regulatory professionals who have managed submissions across multiple programs and jurisdictions, working under a consistent Katogen operating standard.
Capabilities — What We Cover
Regulatory pathway strategy: IND, NDA, BLA, 510(k), combination products
Submission preparation, compilation, and filing
Agency communications and meeting support (FDA, EMA, and other jurisdictions)
Compliance gap assessments and remediation planning
Advertising and promotional materials review
Audit and inspection readiness; mock inspections
Warning Letter and inspection observation responses
Labeling review and technical documentation
Product lifecycle management: changes, renewals, market expansions, discontinuations
Regulatory intelligence monitoring — track changes before they affect your program
Cross-functional coordination with CMC, clinical, and legal teams
Why Katogen — Why Work With Us
Coverage across Rx small molecule, gene therapy, OTC, switch programs, medical devices, and combination products — not a single-modality specialist.
Regulatory planning integrated with Katogen Strategy — aligns with your broader development and financing roadmap.
Senior-led engagement with direct accountability — not passed to a junior team after scoping.
Experienced in both pre-submission strategy and post-submission execution, including crisis response.