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 (we support the full range of contents: Administrative, CMC, Nonclinical, Clinical...aka, Modules 1-5 of the eCTD) to authorship of full documents. We also offer review, gap analysis, and editing of your existing draft documents. 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) and marketing approval (BLA, MAA).
Click here for a list of supported regulatory documentation.
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Our foundational QMS framework enables smaller US-based start-up companies currently using an outsourced supply chain model (e.g. CDMOs and CTOs) to establish a phase-appropriate Pharmaceutical Quality System 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 offering is a QMS framework of core documents and procedures which can be deployed within a quality-controlled space in a phase-appropriate, cost-efficient, user-friendly, scalable, and customizable manner, according to individual customer’s needs. This enables sponsors to initiate vendor qualification of GLP CROs, review and approve Quality Agreements, and conduct audits of CDMOs either by their own internal resources or a contracted QA resource provided by BTL/DHC.
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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