Quality
As a global finished-dose CDMO with over a century 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, from raw material testing to stability studies and regulatory compliance.
Quality resources and insights
Explore our library of resources to learn more about our quality processes and expertise.
The three key trends that will most impact drug development in 2025
The speed of change in the drug development and manufacturing sector requires its stakeholders to be proactive in understanding and addressing key trends and directions the industry is taking. As a global market of considerable size and significance, the value of which is anticipated to grow from $589.06 billion in 2024 to $632.71 billion in […]
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Microneedle array patch characterization recording
Microneedle array patches (MAPs) have the potential to transform delivery of medications and vaccines. While this innovative drug delivery format could result in improved efficiency across a wide range of therapeutics, it also brings critical challenges. To successfully move from concept to commercialization, MAP manufacturers must consider scalability, regulatory compliance, and other complexities. In this […]
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Microneedle array patch characterization presentation
Microneedle array patches (MAPs) are a transformative innovation in drug delivery, with the potential to redefine how medications and vaccines reach patients. MAPs promise a simpler, more effective way to deliver a wide range of therapeutics, but their journey from concept to commercialization is filled with critical challenges. From scaling manufacturing to ensuring regulatory compliance, […]
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Addressing top tech transfer challenges
Technology transfer represents a critical bridge between development and commercial manufacturing. This complex process — moving product and process knowledge between development and manufacturing teams or between different manufacturing sites — demands precision at every stage. The implications of technology transfer extend beyond knowledge sharing. Each decision during this process directly impacts manufacturing efficiency, regulatory […]
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Tech transfer commercial manufacturing mindset
Technology transfer (tech transfer) moves product and process knowledge between teams or partners and acts as a crucial bridge between ideation and commercialization. Especially for complex products like sterile injectables, a smooth tech transfer process is essential. In this white paper, discover valuable strategies to embrace a commercial manufacturing mindset from day one. Download your […]
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HFA152a green propellant capabilities
With evolving regulations and a growing push for sustainability, switching pressurized metered-dose inhalers (pMDIs) to green propellants is becoming increasingly essential. One of the most promising low global warming potential (GWP) options is HFA152a. In this white paper, we share insights on transitioning to HFA152a. Download your copy to discover: An overview of sustainability regulations […]
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Sterile product introduction and tech transfers in a crowded market
The tech transfer landscape for sterile products is increasingly complex, with pressure to reduce time to market. Find out how to navigate common challenges and avoid costly delays or oversights in this presentation from our Director, Client Portfolio & Relationship Management, Kim Brown. Download your copy to explore: Benefits of a commercial manufacturing mindset How […]
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Eliminating the syringe with inhaled and microneedle vaccine delivery systems
Interest in inhaled and intradermal vaccine delivery systems isn’t just a modern innovation — one of history’s most effective vaccination campaigns also used mucosal or dermal delivery. In 1777, George Washington mandated smallpox inoculation for his troops using either arm scratches (intradermal) or nasal inhalation (mucosal), a strategy that proved crucial in the American victory.1 […]
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Leading the way in low-GWP propellants
As regulations surrounding inhalation device sustainability evolve, we help you streamline the process of transitioning to low global warming potential (GWP) propellants. Clinical supply for green propellants HFA152a and HFO1234ze is already available, with commercial scale available this year and plans for further expansion. Download this information sheet to dive deeper into our low-GWP propellant […]
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.