Clinical Trials

Secondary Labelling

Copea Pharma can provide secondary labelling and packaging activities from single patient packs to multi language patient kits. Copea Pharma can perform in house expiry update labelling or provide documentation to sites to ensure that they perform expiry updating in a compliant manner. Ancillary supplies can be sourced and labelled as part of the kitting process.
Copea Pharma has experience of labelling ambient and cold chain products.

Importation

Copea Pharma can provide the QP declaration for your IMP to allow importation into the EU. Copea Pharma’s experienced QPs can certify the finished product. Picking of individual packs to dispatch of pallets of supplies can be arranged and distribution with the EU, US or Rest of World arranged.

QP certification

Copea Pharma’s QPs are experienced in the QP certification of imported bulk, IMP materials or comparator products. A comprehensive list of required documentation is provided at project initiation and the QPs work closely with your clinical team to ensure that the systems are in place to meet your clinical timeframes.

Once certified picking of individual packs to the dispatch of pallets of supplies is arranged and distribution with the EU, US or Rest of World arranged.

Audits

Copea Pharma provide audit services tailored to your requirements. Copea has a team of experienced QP auditors that have a full range of dosage forms ensuring that the auditor fits your project requirements. Copea Pharma will help you to assess your supply chain and recommend any remediation that is required.

Copea Pharma auditors are experienced in remediation programmes where there have been Regulatory inspections that may impact your project and the ability to supply Product(s).

Copea Pharma will work closely with you as the client to ensure that all observations are completed in an appropriate manner within the timescale documented within the response.

Comparators sourcing

Copea Pharma source comparator product from within the EU, US or Rest of World. Pedigree statements are provided to ensure traceability of the supply chain and to comply with the Falsified Medicines Directive 2011/62/EU. Labelling of comparators is provided within our secondary packaging area.

Auxiliary Medicine sourcing

Copea Pharma source Auxiliary medicines for use within your trial such as rescue medicines, skin prick tests etc. Pedigree statements are provided to ensure supply chain traceability and compliance with the Falsified Medicine Directive 2011/62/EC.

JIT labelling

When clinical supplies are limited Copea Pharma work with you to perform Just in Time labelling. We advise what label text can be added without the requirement to re-certify the IMP and in circumstances were drug supply is extremely limited certify a single labelled pack.