Centauri is a growing suite of proprietary resources, tools, and service frameworks developed to enable greater access to the expertise offered by Dark Horse Consulting and BioTechLogic. Informed by decades of experience working with global clients across all stages of development, services delivered through Centauri have been optimized to maximize efficiencies of cost, timeline, and resources, while still delivering the highest value, quality, and expertise you’d expect from us. Additional frameworks are under development.
Our experienced technical writers can provide a full range of support for your filing needs, from individual sections to authorship of full dossiers. We support the full range of contents: Administrative, CMC, Nonclinical, Clinical (Modules 1-5 of the eCTD)
We also offer review, gap analysis, and editing of your existing draft documents.
In terms of publishing, our team’s diverse experience spans a wide range of global jurisdictions and stages of development, from preclinical (INTERACT, pre-IND, Scientific Advice, IND, IMPD, CTA) through clinical (meeting packages, designation requests, IND protocol documents, DSUR), marketing approval (BLA, MAA), and post approval (supplements, request for variation).
Click here for a list of supported regulatory documentation across all stages of therapeutic development.
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QMS in a Box is a foundational framework of core procedures, forms, and templates designed to support smaller US-based start-up companies currently using an outsourced supply chain model.
We provide an established, phase-appropriate, and customizable QMS based on FDA’s Phase 1 GMPs that utilizes recognized cloud-based electronic document and learning management systems (integrated EDMS-LMS) to enable release of Phase 1 GMP clinical trial material.
This enables Sponsors to initiate vendor qualification of GLP CROs, review and approve Quality Agreements, and conduct audits of CDMOs, either through their own internal resources or via a contracted QA resource provided by BTL/DHC. Ultimately, these procedures will be necessary for use by the Sponsor company’s Quality representative to formally release the early phase clinical lot to the clinic.
Future plans include development of GLP and GCP SOPs, and a comparable framework designed to support early phase EU-based manufacturing.
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