REGULATORY AFFAIRS
Expert regulatory support to ensure full compliance for your products.
KS Pharma Services provides comprehensive regulatory affairs support to ensure full compliance with the complex and evolving requirements governing medicinal products, medical devices, food supplements, cosmetics, and biocides. Our expertise enables your products to meet the highest standards of quality, safety, and efficacy across Europe.
We offer tailored regulatory solutions, ensuring compliance with ever-evolving requirements while safeguarding your brand and product integrity.
Our regulatory services include (but are not limited to):​​
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Strategic regulatory consulting
across all stages of the product lifecycle.​
Preparation, review, and submission of regulatory dossiers
in accordance with national and European procedures (e.g., CP, MRP, DCP or national applications) using the correct tools and eCTD software.
Regulatory intelligence and monitoring
ensuring timely adaptation to legislative changes.
Compliance review of labeling and packaging materials
safeguarding the clarity and accuracy of product information.
Post-approval regulatory management
including variations, renewals,...
Support with market entry and expansion
handling the acquisition of licenses and approvals across multiple jurisdictions.
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With KS Pharma Services as your regulatory affairs partner, you can focus on what you do best – innovating and delivering pharmaceutical solutions that improve lives.
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With over two decades of experience, KS Pharma Services acts as a reliable partner, delivering proactive, efficient, and tailored regulatory solutions. Our approach minimizes compliance risks, optimizes approval timelines, and supports the sustainable growth of your business.
Leave the regulatory challenges to us, and together, we'll navigate the intricate path to success in the pharmaceutical industry.
Ready to embark on a journey towards regulatory compliance and pharmaceutical excellence?​
Let's start shaping a future where your products meet the highest standards of quality and safety.