Kivo

450+ ICH clinical protocol template for streamlined authoring and ICH compliance. Fully customizable and pre-formatted ICH templates for FDA, EMA, and more.

Kivo’s eTMF solutions support clinical trial site management, TMF completeness, and site selection for scaling pharma teams.

Kivo’s content management system for life sciences supports DMS asset management and asset protection, and is designed for diligence readiness.

Kivo’s process automation supports GxP compliance by automating workflows, enforcing SOPs, and tracking documents with real-time reporting.

The page discusses how life sciences organizations build scalable, inspection-ready operations through GxP compliance.

TMF Migration - the process of moving an electronic Trial Master File - requires careful planning, coordination, and execution.

Understanding key differences between the MDR and FDA is critical for medical device manufacturers to navigate compliance efficiently.

The page discusses structuring, scaling, and sustaining healthcare quality assurance programs that meet 21 CFR Part 11, ISO 13485, and GxP requirements.

Kivo subscriptions include access to eTMF, RIM, QMS, and eCTD, with no implementation, support, validation, or maintenance fees.

The page discusses migrating from SharePoint to a compliant RIM system.

Compare three practical MasterControl alternatives for growing life sciences quality teams — a DIY tool stack, point solutions, and a unified QMS platform — on cost, timeline, and compliance tradeoffs.

The team has over 100 years of collective experience in Life Sciences, spanning Regulatory, Clinical, and Quality roles at Tier 1 pharma companies and emerging biotechs.

Kivo is a team of regulatory experts and software architects that built a document collaboration solution for emerging pharma teams.

Kivo is the Regulatory, Clinical, and Quality management platform for clinical-stage biopharma. Flexible, modern, GxP-compliant RIM, eTMF, QMS, and DMS.

Kivo and CRISPR Therapeutics will showcase their **52-day Quality Management System (QMS) modernization** at the **DIA 2026 conference** in Philadelphia. The session highlights strategies for pharmaceutical, biotech, and contract research organizations (CROs) to rethink and streamline QMS processes. The presentation focuses on accelerating operational efficiency in regulatory compliance frameworks.

Jun 2026BioSpaceNews article

Kivo introduces **Kivo for Quality**, a validated quality management system (QMS) tailored for pharmaceutical and medical device teams. The platform integrates with Kivo GO to streamline collaboration across Regulatory, Clinical, and Quality functions. It provides compliance-ready tools designed specifically for Quality teams to manage processes efficiently.

Oct 2023kivo.ioNews article

Kivo launches **Kivo GO**, a document management platform tailored for small life sciences teams. The solution integrates workflows across functions while ensuring compliance and security. It targets emerging teams needing efficient collaboration.

Oct 2023Clinical Laboratory int.News article

Kivo launches **Kivo GO**, a unified document management platform designed for emerging life sciences teams. The solution enables cross-functional collaboration while ensuring compliance and security. The platform targets organizations aiming to streamline workflows and accelerate product development timelines.

Sep 2023newswire.comNews article