Learn details about the following list
in Tracy TreDenick's Starter Kit Overview:

I. Virtual biopharma company tendencies and associated risks

II. Signs that it’s time to consider QMS in a Box

III. What does phase-appropriate mean?

IV. Included in QMS in a Box

V. How QMS in a Box works in practice

VI. Required steps for implementation of a QMS

VII. Supported modalities/product types

VIII. Benefits to early-stage companies

IX. Limitations/geographic scope

QMS in a Box is a phase-appropriate, timeline- and cost-efficient turnkey solution for Sponsors needing to establish a Quality Management System (QMS).

Three indicators that it’s time to consider QMS in a Box:

➊ When you first begin identifying  and engaging CROs and CDMOs
(Vendor Management)

➋ When you initiate your ND-enabling toxicology studies
(QA oversight of GLP product)

➌ When you begin preparation for manufacturing your FIH clinical product
(DS and DP) batch (QA oversight and release of GMP product)

QMS in a Box is a foundational framework of core procedures, forms, and templates designed to support smaller US-based start-up companies that are 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.