Cilatus Manufacturing Services Ltd., a subsidiary of PLG, offers comprehensive Qualified Person (QP) certification services, crucial for the pharmaceutical and biotechnology industries. Established in 2017 in Dublin, Ireland, our aim is to provide seamless QP release services for both commercial and investigational medicinal products, ensuring compliance with the highest standards of quality and regulatory requirements.
Our Expertise and Licensing
Cilatus Manufacturing Services Ltd. is duly licensed by the Irish Regulatory Authority, Health Products Regulatory Authority, under license numbers M12235/00001 for Manufacturing and IMP12234/00001 for Importation. These licenses authorize us to perform QP certification for batches intended for export from the EU, import into the EU for sale or use in EU clinical trials, and for products fully manufactured within the EU, ensuring their readiness for the EU market or use in EU clinical trials.
QP Certification Services Offered
Our QP certification services encompass a wide range of activities designed to meet the rigorous standards of product quality, safety, and efficacy:
- QP Release for Commercial and Investigational Medicinal Products: We ensure that every batch meets the necessary quality standards for safety, efficacy, and regulatory compliance before release.
- Importation and Exportation Licensing: Our services include the facilitation of smooth importation into and exportation from the EU, ensuring compliance with all regulatory requirements.
- Comprehensive Regulatory Compliance: Leveraging DSI’s extensive experience in regulatory affairs, we guide our clients through the complexities of EU regulations, ensuring full compliance.
- Strategic Advice and Support: Our team offers strategic advice on QP certification and regulatory strategies to optimize the speed and efficiency of product market entry or clinical trial commencement.
- Risk Management and Quality Assurance: We conduct thorough risk assessments and implement quality assurance measures to mitigate risks associated with product quality and regulatory compliance.
Why Choose Cilatus Manufacturing Services Ltd.?
Choosing Cilatus Manufacturing Services Ltd. for your QP certification needs means partnering with a team that not only understands the intricacies of pharmaceutical regulations but also values the importance of your time and investment. Our team of seasoned professionals, with their hands-on approach and strategic guidance, ensures that your products meet all regulatory standards and reach the market or clinical trial phase without unnecessary delays.
With our comprehensive services, extensive regulatory knowledge, and commitment to quality, Cilatus Manufacturing Services Ltd. is your ideal partner for navigating the complex landscape of QP certification and pharmaceutical product release.
