Nathan Blazei Joins Kymanox as Head of Quality

DURHAM, NC –March 30, 2021 — Kymanox, a full-service life sciences solutions provider supporting commercialization of vital medicines and treatments, is proud to announce the addition of Nathan Blazei as Head of Quality. This new role will allow Kymanox to further enhance quality, regulatory, and compliance services for life science …

On Demand – Lessons from Inspiring Women Life Science Leaders: A panel discussion to celebrate International Women’s Day

“As women, our ability to pivot and persevere when our lives become disrupted has become a leadership advantage!”  ~Jennifer Johns  “Less than 2% of venture capital goes to women. We need to have more women at the table to shift the perspective.” ~Ashley Kalinauskas “Even though women are in the …

Lessons from Inspiring Women Life Science Leaders: A panel discussion to celebrate International Women’s Day

Monday, March 8, 2021 from 1pm-2pm EST Register Here Join Kymanox for a discussion with these three leaders as they talk about their experience working in the life sciences sector.  We’ll cover challenges women face in business, ways to lift up and support each other, and the importance of celebrating successes.  …

How the FDA Defines Combination Products

Is your product a combination product?  Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products.  The FDA identifies.Take a look at the table below to see if your …

Perspective Article: Key Packaging Challenges to Consider in Gene and Cell Therapies

The Importance of Packaging Design Early in the Development Process Cell and gene therapy technologies, the once touted technologies of the future, are presently being used to treat patients. Every month biopharmaceutical companies develop innovative treatments using gene, chimeric antigen receptor (CAR) T-cell, and stem cell technologies.1 Great excitement exists …

Human Factors Planning 101

Human Factors…. it is increasingly becoming a part of product development these days but what does it really mean? Furthermore, how does it apply to the life sciences industry? If these questions are important to you, you are in the right place. The Human Factors and Ergonomic Society (HFES) has …

Creating Robust Building Maintenance and Environmental Monitoring Systems for Your CGMP-Compliant Facility

by Faith Fraley, Director, CQV Engineering at Kymanox Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products and processes. Deviations can be disastrous, but environmental controls mean nothing if they aren’t properly qualified and validated. A programming issue with humidity controls could …

Cognitus and Kymanox Announce SAP Strategic Partnership

Strategic alliance signed with SAP Gold Partner Cognitus FOR IMMEDIATE RELEASE MIAMI, April 24, 2020 /PRNewswire/ — Cognitus Consulting, LLC (Cognitus) and Kymanox Corporation (Kymanox) have approved a strategic partnership to streamline FDA compliant SAP S/4 HANA solutions for Life Sciences organizations. The joint offering is being branded as “Gallop for Life Sciences – …

Points to Consider When Validating Computer Systems for CGMP Processes

Jim Falanga, Director, CSV Compliance Tara Doby, Sr. Validation Specialist Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require life science companies to have controls on computer systems that are used to manage CGxP electronic data and records.  As part of the implementation and maintenance …

Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution

by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title …