Copea Pharma provides importation for clinical, commercial and unlicensed medicinal products. With material being imported into our warehouse facilities based in Liverpool.
For commercial products Copea Pharma can arrange, sampling and importation testing upon entry into the EU.
Copea Pharma provide QP certification for both clinical and commercial imported bulk and finished products.
Copea Pharma certify and hold your clinical trial or commercial bulk product. A full list of required pre-requisites and documentation will be provided at project set up.
A Qualified Person will be available to give advice on all aspects of the project to ensure certification within the agreed timeframes. Dispatch of your bulk for onwards processing can be arranged using one of our vendor approved courier companies.
Finished Product Certification
Copea Pharma certify and hold clinical trial or commercial finished product. Copea Pharma has the capability of storing products at 15 – 25°C and 2 – 8°C within our facilities based in Liverpool.
Copea Pharma’s experienced QPs have knowledge of dosage forms including aseptics, terminally sterilised, oral solid dose, creams, ointments, liquids, transdermal patches, granules, powders, radiopharmaceuticals, biologicals, biotechnology and inhaled formulations.
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.
Your main point of contact for your project is a Qualified Person ensures that the project transitions as quickly and smoothly as possible. The Copea Pharma Qualified Person is available for technical input at all stages of your project. A detailed project plan is included as part of the project set up.
Copea Pharma provides a review of your current QMS including a gap analysis against current and forthcoming legislation to ensure that your QMS meets current and any upcoming requirements.
A remediation programme can be put in place to ensure any recommendations are completed.
Self Inspection Programmes
Copea Pharma can be relied onto be your partner in your self inspection program. Copea Pharma works with you to ensure that you get the most from the program, including a pre-schedule risk assessment to ensure that those areas of concern are covered.
Copea Pharma works closely with your staff to ensure adherence to the schedule.
Inspection Readiness Preparation
Copea Pharma staff host Regulatory audits from agencies including MHRA, FDA, Envisa. We perform a gap analysis on your Quality Management System prior to a regulatory inspection. We can work with you to implement a remediation programme to ensure that your Quality Management system is robust.
Copea Pharma can coach and mentor your employees in interacting with the external auditors.