Regulatory and QP services

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We provide the following QP services:

QP batch certification: QP confirms that the operations performed on-site has been carried out following GMP, as well as all the procedures specified by the technical agreement.
QP batch release: after the certification and depending on the scope, our QPs can cover the first step of the release as well. Within its framework, QP confirms that the batch of IMP has been manufactured in compliance with EU GMP, Investigational Medicinal Product Dossier (IMPD) or the Clinical Trial Authorisation (CTA), and the Product Specification File (PSF).
QP consultation services, participation in meetings and regular conference calls, proactively informing clients about the latest information on EU regulatory updates.

ClinPack was recommended by the CRO as a clinical supply service provider for our Phase II blinded, randomized study conducted in Central Europe. They ensured the seamless importation of 12 pallets of IMD, completed full labelling in a single day, and managed shipments within the required timeframe, quality, and budget. They proactively flagged potential cost increases, and in parallel provided proposals for us to act efficiently contributing to ensure that the study was proceeding as planned. They contributed to ensuring that the study progressed according to plan. ClinPack is a client-focused, reliable, and professional clinical supply service provider partner.

Sana Alajmovic | Co-Founder & CEO

Sigrid Therapeutics

ClinPack came to our attention in relation to the assembly, storage, and delivery of patient kits required for a Phase II trial conducted in Europe andUS. They have executed with precision complemented by their commitment to providing the best value without compromising on quality. With deep professional expertise, a customer-focused approach, and flexibility, ClinPack contributed to the smooth progression of our trial. They are a reliable and professional clinical supply service provider partner that we can always count on.

Asaf Cohen | SVP CMC and Operations

SpliSense

Regulatory and QP services

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