Pharmaceutical Solutions | Kymanox | Life Science Solutions Partner

Pharmaceutical Services

Kymanox gives you peace of mind by providing technical experience to make your product a success.

Development & Operations

• Product & Process Development

• CMC Services & Analytical Sciences

• Process Engineering

• Human Factors Regulatory & Strategy (HURAS)

• Packaging Technology & Engineering

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Quality, Regulatory, & Compliance

• Quality Assurance, Compliance & Auditing

• Quality Engineering

• Quality Control

• Regulatory Affairs

• Clinical & Medical Affairs

• CGxP Microbiology & Environmental Monitoring

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Commissioning, Qualification, & Validation

• Validation Master Planning

• Facilities & Utilities CQV

• Lab & Plant Equipment CQV

• Computer System Validation (CSV)

• Process Validation

• Cleaning Validation

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Strategy, Planning, & Execution

• Program & Project Management

• Technology Transfer

• Innovation Solutions

• Enterprise Resource Planning & Solutions

• Due Diligence

• Staffing Solutions

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Pharmaceutical Products & Services Where We Excel

Bulk Drug Substance (BDS) / Active Pharmaceutical Ingredient (API)

BDS/API

Drug Product

Drug Product

Contract Development & Manufacturing Organizations (CDMO)

CDMO

Meet our Pharmaceutical Experts

Ryan Doxey

SENIOR DIRECTOR, TECHNICAL SERVICES

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 for cell and gene therapy 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 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 cell and gene therapy 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 structured 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.