Integration
End-to-end turnkey services integrated with your internal team
Quality & Regulatory Services (QRS)
Strengthened by comprehensive Qualified Person (QP) and Quality & Regulatory Services (QRS), we support your drug development and commercialization journey end-to-end.
Uncompromising quality
As a leading global CDMO, we provide fully integrated manufacturing, packaging, and supply chain solutions, backed by deep regulatory and quality expertise. Our comprehensive Qualified Person (QP) and Quality & Regulatory Services (QRS) are designed to support every stage of your drug development and commercialization journey.
Assured at every step
Our experienced Qualified Persons (QPs) play a pivotal role in bringing products to market, ensuring full compliance across every stage of the product lifecycle, from clinical trial supply through to commercial launch. Their expertise spans site audits, supply chain management, quality oversight, and the market release of both clinical and commercial products. Through this comprehensive support, we ensure that every product meets global regulatory standards while maintaining operational efficiency.
Our teams provide tailored support to help navigate the complexities of modern drug development. Whether an emerging biotech or an established pharmaceutical company, we offer flexible, scalable solutions that align with development strategies, ensure regulatory compliance, and accelerate the path to market.
Core capabilities
CMC consultancy and dossier authoring services provide full or partial support for regulatory submissions, as well as independent review of third-party CMC documentation to ensure accuracy, completeness, and compliance. Regulatory strategy and support services provide expert guidance for scientific advice and end-of-phase meetings, supported by regulatory intelligence that helps you anticipate and meet global requirements. PSF Fast-Track Readiness support ensures your documentation is fully aligned and optimized to expedite EU clinical trial start-up, helping you move quickly and confidently into first-in-human studies.
Our commercial readiness services provide local market insights and registration support that seamlessly complement your in-house regulatory capabilities. Our standalone quality services provide targeted support across critical quality functions, including Person-in-Plant oversight, deviation investigation, Quality Technical Agreement (QTA) development, QMS design and implementation, and comprehensive regulatory inspection readiness.
Clarity and control
From project launch through commercial supply, our Quality & Regulatory Services (QRS) team acts as an extension of your internal organization, providing adaptable support at every stage. We deliver tailored solutions aligned with your product, program, and regulatory milestones, supported by dedicated subject-matter experts tailored to your specific needs. A detailed RACI matrix clearly defines roles and responsibilities, ensuring seamless collaboration, accountability, and project efficiency.
Our process and SOP development strengthen your quality systems by designing or enhancing procedures and workflows tailored to your operational needs, which cover:
- Vendor management
- Deviation management
- Change Control
- Lot release
- Validation
- Complaint handling
- Recall and recovery
We are inspired by tomorrow
Forsight
Global market expertise and regulatory foresight
Anticipation
Early gap analysis to anticipate and address regulatory challenges
Access
Access to a broad network of specialized consultants
Non-Sterile Development & Manufacturing
World-leading science and minds supporting process development, formulation, and optimization on the pathway connecting your product to patients
Learn more about our non-sterile capabilities and how we deliver safe, reliable, and scalable solutions across a broad range of oral dosage forms.
Contact us today to talk to our expert customer services team about how we can support you with non sterile drug QP services.