Quality
As a global drug delivery CDMO with a rich legacy of experience, we maintain an unwavering commitment to ensuring that quality and compliance are embedded in every step of the drug-device development process, from ideation through post-commercialization. Our investment in state-of-the-art facilities, cutting-edge technologies and advanced analytical capabilities demonstrates our dedication to providing strategic value that extends beyond manufacturing.
Quality: Exceptional by design
We operate within Quality by Design (QbD) principles, ensuring that quality is embedded in every stage of the development and manufacturing process. Our experts have extensive experience in meeting both medical device and pharmaceutical requirements from regulatory bodies worldwide.
Full compliance with current Good Manufacturing Practice (cGMP) guidelines
We maintain full compliance with current Good Manufacturing Practice (cGMP) guidelines, including:
- CFR 210
- CFR 211
- CFR 820
- 21 CFR Part 4
- ICH Q1A through Q10
Understanding our QbD approach
1. Customer
- Alignment to customer expectation
2. Leadership
- cGMP focus
- Quality 1st behaviors
3. People
- Data integrity and right-the-first-time
4. Process
- State-of-the-art processes
- Real-time continuous process
5. Improvement
- Proactive signal management
6. Evidence-based decision making
- Risk based CQV driven
7. Relationship management
- Proactive communication
- Transparency
- Partnership
Quality capabilities
We embed quality into every product and process, aligning with QbD, Six Sigma and Right First Time (RFT) methodologies to ensure exceptional quality from inception.
We provide full compliance with cGMP guidelines and comprehensive support for CMC sections of regulatory submissions, including INDs, European filings, DMFs and ANDAs.
Our Bridgeton facility is designed to achieve complete Annex 1 compliance for sterile drug manufacturing, ensuring the highest standards of sterility assurance.
We leverage advanced automation strategies to optimize your supply chain, minimize risk and enhance production efficiency.
Kindeva utilizes automated measuring equipment to ensure repeatable, reliable and consistent quality throughout the manufacturing process.
With decades of experience navigating international regulatory and quality standards, we facilitate the seamless shipping and sales of combination products worldwide. We hold all necessary ISO certifications, ensuring compliance with global standards.
Our postmarket support services maintain rigorous quality and compliance standards, from product intake through analysis, ensuring the ongoing success of your therapy.
We implement proactive, non-destructive evaluation methods, including X-rays and CT scans, to assess the quality and integrity of products and components.
We prioritize product reliability, exceeding industry standards with a focus on “four and five nines” reliability. Our commitment to quality, combined with Annex 1 compliance for parenteral products, ensures that your product meets the highest expectations for performance and safety.
Our regulatory experience and historical know-how in microneedle technology enable us to prioritize patient comfort and compliance by providing pain-free delivery solutions, addressing the needs of needle-phobic patients.
Backed by over a century of experience, our analytical and testing services encompass every stage of your combination product’s lifecycle, with expanded capabilities in IVBE, functional testing and regulatory support.
Quality resources and insights
Explore our library of resources to learn more about our quality processes and expertise.
Career journeys blog 3: Lauren Harrison
In this story, we meet Lauren Harrison, a formulation scientist who began her path as an apprentice and has spent the last decade building a career rooted in curiosity, hands-on learning and collaboration.
Learn More
Navigating the transition to next-generation propellants for pMDIs | On-demand webinar
Regulators, health systems and patients expect meaningful progress on sustainability. For pressurized metered dose inhalers (pMDIs), this means planning the transition to low global warming potential (low-GWP) next-generation propellants (NGPs) now, not at the end of the decade. In this webinar with Pharmaceutical Technology, Craig Somerville, Senior Vice President of Kindeva’s pMDI business unit, shares […]
Learn More
Beyond the contract: Driving transformational partnerships with manufacturing… and more
Achieving scientific breakthroughs is just one hurdle in today’s drug development and manufacturing process aimed at improving patient outcomes. Bringing a new therapy to market requires meticulous execution and clear communication at every step. Unfortunately, even the most groundbreaking scientific advancements can be delayed or even entirely abandoned due to poor performance from partners. This […]
Learn More
Why Kindeva: Analytical and regulatory services
Overcome complex analytical and regulatory challenges with a partner dedicated to your product’s success. Our specialist expertise helps you navigate testing, compliance, and quality to advance your project from concept to commercialization. Download our one-pager for a closer look at our integrated approach, including: An overview of our comprehensive, phase-appropriate analytical services. How our regulatory […]
Learn More
Career journeys blog 2: Oliver Ingham
In this latest installment, we meet Oliver Ingham, an analytical chemist whose curiosity and problem-solving skills have shaped his journey from academic research to coordinating analytical development services at Kindeva.
Learn More
Career journeys blog 1: Holly Dowdle
When Holly Dowdle first joined Kindeva as a student intern, she experienced a workplace that valued both curiosity and collaboration. It was an environment where asking questions was encouraged and development was part of everyday work, not something that happened on the sidelines.
Learn More
A bridge between design and delivery: Exploring sterile fill finish integration for injectable product success
The global sterile injectable contract manufacturing market is experiencing rapid growth, driven by increasing demand for advanced biologics, glucagon-like peptide-1 (GLP-1) therapies and other injectables. These products pair drugs with delivery devices to support patient-centric care, but their manufacturing presents unique challenges. Programs often require specialized environments, such as cold-chain storage and low-volume fills, and […]
Learn More
Going beyond manufacturing: The Kindeva customer experience
Going beyond manufacturing: The Kindeva customer experience As development timelines tighten and product complexity grows, the quality of CDMO partnerships has transformed into a critical success factor. In today’s high-stakes landscape, drug developers need more than technical execution. They need partners who embed early, stay aligned and help navigate every phase of the product lifecycle. […]
Learn More
Built for better tomorrows: How Bridgeton delivers for patients
Kindeva’s Bridgeton facility offers a purpose-built solution for the complex and evolving landscape of injectable drugs. The facility was specifically designed to address challenges in sterile injectable manufacturing, such as the siloed approaches that often separate core functions like formulation and fill finish. By co-locating these functions and operating within integrated systems, the Bridgeton model […]
Learn MoreLet’s transform tomorrow together
Every patient deserves a brighter tomorrow. As your strategic partner, we are dedicated to building your lasting legacy and helping you fast-track healthier tomorrows. You dream it, we deliver it.