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At Cohance Lifesciences, quality is not a department. It is a deeply embedded mindset—an organizational consciousness that shapes every decision, every action, and every solution we deliver. As a global CDMO committed to advancing health science, our Quality and Compliance practices are guided by scientific integrity, regulatory vigilance, and a shared responsibility to improve human lives.
At Cohance, our ESG strategy is rooted in balancing scientific innovation with environmental stewardship, social responsibility, and ethical governance. Guided by four pillars—Environmental Resilience, Empowering People, Collaborating for Community Impact, and Building Trust—we deliver sustainable solutions for a healthier world. Our commitment drives us to partner with global life sciences companies, offering integrated, innovative solutions with speed, flexibility, and care.
We prioritize minimizing our ecological footprint through:
Our Environment, Health & Safety (EHS), Energy, and Biodiversity Policies guide our efforts to foster a resilient, sustainable future.
Our unwavering commitment to quality begins with a simple yet powerful belief: people deserve the best. That is why we do not just adhere to global standards—we consistently exceed them. From research and development to manufacturing and distribution, every product we create aligns with the most rigorous global regulatory requirements, ensuring Safety, Identity, Strength, Purity and Quality (SISPQ). This standard of excellence underpins our promise to patients across the world.
Quality at Cohance is more than just a process—it is a culture. Our core values—Customer First, Accountability, Sustainability, Trust, and Empowerment—fuel a collective commitment to continuous improvement and patient well-being. Every individual is empowered to take ownership of quality outcomes, creating a proactive, detail-oriented environment where excellence is a shared pursuit.
Our Quality and Regulatory Affairs team is one of our strategic assets. Our teams in QA, QC, CQA, DQA, and RA embed quality into the very DNA of every product, process, and delivery. Their expertise not only secures regulatory compliance but also strengthens our ability to meet evolving customer expectations and global market access needs.
Navigating the complex global regulatory landscape is a responsibility we take seriously. We design our operations for compliance at every step—from development through distribution—so we consistently meet and often exceed the expectations of health authorities across geographies. This approach reinforces the trust placed in us by our partners, patients, and regulators worldwide.
Our facilities across API, FDF units carry prestigious approvals from health authorities such as the US FDA, EDQM, PMDA, ANVISA, WHO-GMP, KFDA, COFEPRIS, HEALTH CANADA, MHRA, and DCA, among others. These approvals are more than checkmarks—they are a reflection of our discipline, consistency, and commitment to making high-quality pharmaceuticals accessible across borders.
Our Integrated Global Quality System is a unified framework that ensures every Cohance product—regardless of where it is developed or manufactured—meets the highest international benchmarks. By harmonizing standards, processes, and compliance practices across our network, we guarantee consistency in quality and safety from lab to market.
We are embracing digital transformation to make our Quality Management System even more agile and intelligent. We use digital tools and automation to enhance data integrity, improve traceability, and ensure faster, more reliable compliance with both global and local regulations. This ongoing digital evolution reflects our future-ready commitment to patient safety and operational excellence. For a healthier world. That is our commitment, without compromise.
At Cohance Lifesciences, every facility stands as a testament to our uncompromised commitment to quality. Below is a snapshot of the regulatory approvals and certifications that reinforce our global credibility:
FDF Unit I
• US FDA, Health Canada, MHRA, ANVISA, COFEPRIS, Russia MOH, TGA, Philippines FDA, Tanzania FDA, Greece NOM, Uganda NDA, Germany, SFDA, CDSCO, DCA
FDF Unit II
• CDSCO, DCA
CR Bio
• US FDA, DCGI, MOH Turkey, BPFK Malaysia, WHO Geneva, MHRA, GCC, NPRA Malaysia
Unit 1 to Unit 4, and Unit 6
• British Safety Council, International Safety
• ISO 20400:2017, ISO 22301:2019, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 50001:2018
Unit 5
• US FDA, DCA, PPD Global Quality Compliance, EU, CDSCO
• ISO 22301:2019, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 50001:2018
Casper
• US FDA, DCA
Cohance is committed to a sustainable future with ambitious goals:
At Cohance, ESG is our promise to go above and beyond, shaping a sustainable future for health science through passion, expertise, and unwavering responsibility.
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Our great team of more than 1400 software experts.
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Engitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,
Our great team of more than 1400 software experts.
We’ll help you test bold new ideas while sharing your.
Engitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,