Pharmaceutical Services
Kymanox gives you peace of mind by providing technical experience to make your product a success.
Development & Operations
Quality, Regulatory, & Compliance
Commissioning, Qualification, & Validation
Strategy, Planning, & Execution
Pharmaceutical Products & Services Where We Excel
Bulk Drug Substance (BDS) / Active Pharmaceutical Ingredient (API)
BDS/API
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• Product Development
• Quality Assurance, Compliance, & Auditing
• Quality Control & Environmental Monitoring
Drug Product
Drug Product
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• Development Strategy & Planning
• Manufacturing Support
• Regulatory Filing
Contract Development & Manufacturing Organizations (CDMO)
CDMO
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• Evaluation & Selection
• Management
• Tech Transfer
Meet our Pharmaceutical Experts
Ryan Doxey
DIRECTOR, TECHNICAL SERVICES AND CMC
Frequently Asked Pharmaceutical Questions (FAQs)
Can I just outsource this work to Kymanox?
In short, yes. Kymanox has a flexible approach with our clients that is based on the unique needs of that particular situation. In some situations we basically act as employees of our clients, effectively acting as a functional department within their company. You can’t tell a Kymanox employee apart from our clients in these situations. We have additional options to meet your needs as well. One advantage to the Kymanox approach is that we empower our team of full-time employees and contractors, with access to our entire team of experts so when you hire Kymanox you get the benefit of our collective experience. We invite you to learn more about our Staffing Solutions.
I have a pretty big project. Can Kymanox handle it?
Kymanox has extensive experience on multi-million dollar projects at some of the largest pharmaceutical, biologics, and medical device companies in the world. Our processes were built with the ability to scale to meet the needs of a virtual biotech startup, the largest of big pharma, and everything in between. One key to our success is our Program & Project Management <hyperlink to the service interior page> team, our secret weapon in making sure we stay on track with our agreed upon scope and keeping clients informed so they can rest easy knowing there will be no surprises. Our approach is flexible so you’ll get just the right amount of project management for your needs.
What is Ideal Knowledge Transfer™?
Ideal Knowledge Transfer™ (IKT™) is a continuously improving concept that seeks to address the knowledge transfer process in a formal and structure way where end-goal success can be predicted and measured. IKT™ builds on existing principles and disciplines, such as professional project management, fundamental engineering practices, universally recognized quality systems, and formal problem solving methods.
Leveraging our corporate DNA of IKT™, our talented team partners with global clients to facilitate development and delivery of products with optimized safety, quality, efficacy, accessibility, and efficiency. To learn more about IKT™ please visit our IKT blog post (currently at https://kymanox.com/ideal-knowledge-transfer/)
Read the Latest at Kymanox
Nathan Blazei Joins Kymanox as Head of Quality
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,...
On Demand Webinar: Lessons from Inspiring Women Science Leaders for International Women’s Day
"As women, our ability to pivot and persevere when our lives become disrupted has become a leadership advantage!" ~Jennifer Johns
https://kymanox.canto.com/direct/video/lfjpc5oos96hjeis95ger0ib6u/COge77h8J0ePzIoIvDXSggh3J_w/original?conte...
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 identifie...