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Qualified Person certification

High-quality sterile drugs, made simple. Always responsive, always ready to provide QP support.

Qualified Person support at each step

Our expert regulatory team features 3 Qualified Persons (QPs) who are here not just to certify our own licenced medicines, but yours too.

With their support, we ensure that your medicines comply with the requirements outlined in marketing authorizations and licences. Our QPs are independent and are here to make impartial decisions, so you can be confident that their approval guarantees compliance.

Approval for licenced and unlicenced medicines
Our QPs can release fully licenced products under multiple licences, including a commercial manufacturer/importer’s (MIA) licence. They can also release unlicensed batches under our MS licence, and clinical batches under our IMP licence.

Support throughout development
Wherever you are in your product development journey, our QPs can provide expert guidance and support. Our QPs work closely with you and our contract development team to provide the advice and insight you need streamline your project delivery.

A team ready to work with you
We have multiple permanent QPs on our licence, allowing for capacity and continuity in our operations. We continuously invest in staff development to ensure we have the right people and skills to meet the growing demands of our business.

Our capabilities

Our QP offering includes:

QP review and certification of GMP records

Release of fully licensed products

Release of products under commercial manufacturer/importer’s (MIA) licence

Release of unlicenced batches under MS licence and clinical batches under IMP licence

API site audits

Quality and compliance

Our skilled QP team understand global regulatory complexity, and can help ensure the drugs you send to market are compliant with local requirements.

QP support
Our Qualified Persons (QPs) are here to assist you in ensuring that your sterile supply of licenced, unlicenced and clinical products have the required documentation for regulatory compliance.

Compliance with quality standards
We ensure compliance with regulations and the current requirements of the Good Manufacturing Practice (GMP).

Customer support

Our customer support team can guide you in accessing and exporting our products post-QP certification.

Expertise in export regulations
We understand the export regulations of major markets, and can support you in shipping in compliance with all applicable laws.

Assistance with documentation
We can support with the preparation of necessary documentation, including certificates of origin and export licences.

Single point of contact
We offer a dedicated team member to support you in meeting all of your manufacturing and shipping needs.

Sterile supply, made simple

Contact us to learn how we can partner with you to deliver
the sterile supply you need.