Verista, a leading consulting firm focused on compliance services primarily to the pharmaceutical and biotech industries, announced a collaborative partnership with INCOG BioPharma Services, a newly formed Contract Development and Manufacturing Organization (CDMO) also based in Fishers, Indiana. Through the partnership, Verista will provide comprehensive engineering, automation and validation services in a long-term managed service agreement.
The managed service program, Verista 360o, highlights a dedicated team of highly skilled engineers, Verista’s deep industry knowledge of GAMP5, GMP and GDP processes and technology powered by Kneat, an industry leading electronic validation platform. The Verista 360o Program enables INCOG BioPharma Services to focus on their core competencies; scale its business; and optimize resources and industry best practices by outsourcing engineering services execution. The innovative service delivery approach incorporates people, process and technology as a true extension of INCOG’s key in-house technical capabilities.
Verista is proud to be a part of INCOG BioPharma Services’ mission to help patients by developing lifesaving medicines.
“This partnership with Veristais a great catalyst that enables INCOG BioPharma Services to focus on accelerating and ramping up operations to supply the BioPharma industry and patients with lifesaving medicines, while ensuring our engineering and automation platforms are designed to meet best-in-class industry standards,” said Alex Haig, Vice President of Engineering, INCOG BioPharma Services.
“We are pleased about our new partnership with INCOG BioPharma Services,” said Manny Soman, Chief Executive Officer, Verista. “It is great to see two Indiana-based pharma organizations forging a strategic alliance and finding ways to build effective and efficient ways to do business together, ultimately helping both organizations reach their respective outcomes. We are proud to be a part of INCOG BioPharma Services mission to help patients by developing lifesaving medicines. Verista’s collaborative managed service solution, incorporating the Kneat platform, helps expedite the achievement of the mission.”
Verista has emerged as a preferred partner of Kneat. The alliance enables Verista to provide a full-scale managed service offering enabling pharmaceutical and biotech manufacturers the ability to wholly outsource segments of their compliance requirements. The outcome-based model offers a phase-wise transition of their client’s services into a managed mode, with the motto of continuous improvement.
“We are very pleased to have Verista as a Kneat certified partner to enable the Life Sciences industry to digitize their work processes,” said Rick Mineo, Director of Strategic Partnerships at Kneat. “Leveraging our leading technology, Verista positions itself to provide innovative and comprehensive solutions to their customers. We look forward to scaling those solutions and our partnership.”
Verista 360oaddresses the most challenging problems with a primary goal of helping clients move closer to their strategic initiatives, while the Verista team drives the achievement of business outcomes providing end-to-end management, resource optimization and cost savings through day-to-day execution.
Verista offers transformative compliance, automation, validation, and packaging solutions to leaders in the pharmaceutical, life sciences, biotech and med device industries. Verista was launched in 2020 by bringing together three trusted firms: Clarke Solutions, Covex LLC, and Acquire Automation. Verista acquired Hawkins Point in 2021. Verista’s customers trust our 500+ experts to deliver consistent, safe, and high-quality results. Verista’s consultants bridge the traditional chasm between IT and operations, following repeatable processes that deliver solutions for individual devices, capital equipment, site and enterprise-wide systems, and regulatory and sales. Verista, a holding of private equity firm Lightview Capital, is based in Fishers, Indiana, and Wayne, Pennsylvania. For more information, visit www.verista.com.
About INCOG BioPharma Services
Founded in June 2020, INCOG BioPharma will offer development and manufacturing services to both early phase and late phase biopharmaceutical companies—with specific services to include formulation development, analytical method development, process scale up, formulation/filling of biopharmaceuticals into vials, syringes and cartridges, and an integrated solution of specialized packaging services to include labeling, device assembly, final packaging and integrated storage solutions at various temperature conditions. For more information about INCOG BioPharma, visit www.incogbiopharma.com.
Kneat, a Canadian company with operational headquarters in Limerick, Ireland, develops and markets the next generation Kneat Gx SaaS platform. Multiple business processes can be configured on Kneat Gx from equipment to computer system validation, through to quality document management.
Kneat Gx allows users to author, review, approve, execute testing online, manage any exceptions and post approve final deliverables in a controlled FDA 21 CFR Part 11/ Eudralex Annex 11 compliant platform. Macro and micro report dashboards enable powerful oversight into all systems, projects, and processes world-wide. Customer case studies are reporting productivity improvements in excess of 100% and a higher data integrity and compliance standard. For more information visit www.kneat.com.