Succesfull ISO 9001:2015 afresh

February 25, 20212021.02.26.

We at ClinPack Ltd. work in EU-GMP/ISO matrix. We are proud to announce that we passed afresh a successful ISO 9001:2015 audit on the 24th of February 2021.

Its scope is wider than the GMP certificate. The process includes QMS development, documentation review, pre-audit, initial assessment, and clearance of non-conformities.

ISO certification means that our provided services are safe, reliable, and meet international standards. Moreover, we are going to keep investing in technology, development, processes, and procedures to demonstrate our commitment to providing quality of service, effective cost, and timely delivery.

Here is what our clients are saying about us.

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. 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 and US. 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

We collaborated with ClinPack in a Phase II double-blind randomized dermatology clinical trial, and they provided the IMP labelling and clinical logistics services. Both parties entered the project as newly established companies, yet this posed no obstacle to effective set-up and collaboration. Throughout the project, ClinPack proved to be a flexible and proactive partner. We greatly appreciated their transparent communication, agile approach and professional commitment to do everything within their means to ensure that the study progressed in line with the planned timelines.

Anfisa Shakhova | Director Business Development

Niche mid-size European CRO

I approached ClinPack with a regulatory question related to the manufacturing activity and authorization of an investigational medicinal product (IMP). Not only did I receive a clear and accurate response, but they also provided valuable guidance on interpreting the relevant regulations and databases. What I particularly appreciated was their prompt support and the fact that they approached the issue from the client’s perspective. Their assistance enabled us not only to stay compliant but also to make the most of the opportunities within the regulatory framework.

Csilla Léka - General manager

Hungarian Clinical Trials - Global Kft.