Combination Product Quality

A foundation of quality

At Kindeva Drug Delivery, quality is at the core of everything we do. As a top five global combination product CDMO, we have an ongoing commitment to ensure both quality and compliance are built into every step of the drug-device development process, from ideation through post-commercialization — and we have more than a century of success stories to prove it. 

We work within Quality by Design (QbD) principles that align with our right-the-first-time mentality. When you combine forces with Kindeva, you’re choosing industry-leading quality and reliability that bolsters the success of your complex combination product. 

Our team of innovators has a solid track record of experience and demonstrated competency with both medical device and pharmaceutical requirements from regulatory bodies all over the world, including full Current Good Manufacturing Practice (cGMP) compliance, CFR 210, CFR 211, CFR 820, 21 CFR Part 4, and ICH Q1A through Q10.

How CDMO Quality Systems Affect Your Product

01. Customer

  • Alignment to customer expectation

02. Leadership

  • cGMP focus
  • Quality 1st behaviors

03. People

  • Data integrity and right-the-first-time

04. Process

  • State-of-the-art processes
  • Real-time continuous process

05. Improvement

  • Proactive signal management

06. Evidence-based decision making

  • Risk based CQV driven

07. Relationship management

  • Proactive communication
  • Transparency
  • Partnership

Quality capabilities

Our targeted quality capabilities include but are not limited to:

We design quality into the product and the process, aligning with Quality by Design, Six Sigma, and RFT (Right First Time) methodologies 

Compliance with current regulatory cGMP including management of required documentation and compliance procedures; preparation of CMC sections of investigational new drug applications, European filings, applicable drug master files, and abbreviated new drug applications; and manufacturing and testing services including documentation review 

We offer Annex I compliance for sterile drug manufacturing, with every line in our Bridgeton facility designed and built to achieve this compliance 

Our optimized automation strategies mean less supply chain risk for you 

We utilize automated measuring equipment to create repeatable, reliable, consistent quality throughout the manufacturing process 

We have decades of experience navigating international regulatory and quality standards to facilitate shipping and sales of combination products all over the globe, and we hold the necessary ISO certifications 

Our postmarket support is compliant from intake through analysis 

We implement proactive evaluation time using nondestructive methods to assess products and components 

Our reputation for quality is second to none, with full-service capabilities solving complex drug-device combination product challenges serving multiple molecule classes 

With an increasing number of sponsors dissatisfied by the quality and capacity capabilities of many CDMOs, Kindeva confidently fills the gap with an increased emphasis on four and five nines product reliability in addition to our Annex I compliance for parenteral products

Our regulatory experience and historical know-how in this product space position us perfectly to help you navigate the nuanced approval process for this new technology; we also provide increased compliance through pain-free delivery to support use among needle phobia patients   

From supplier and operations management through to postmarket, Kindeva provides consistent quality throughout the full life cycle of your complex combination product. 

Related Resources

Combine Forces With Kindeva

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