SERVICES

At Cope Pharma Consultancy, we provide a service tailored to your company’s requirements. Working closely with our clients, we can deliver a friendly, efficient and cost-effective service for both Human Pharma and Veterinary Products.

We have considerable experience in the GMP auditing of CMOs, CROs, APIs, Raw Materials, Excipients, Medical Devices and Packaging Materials.

We have extensive expertise in stability report writing and the preparation of CMC documentation.

For details of the main services we offer, please see below:

GMP Auditing of CMOs 

We can supply lead auditors for GMP auditing of CMOs. We have experience in auditing the following dosage forms for both Human Pharma and Veterinary products : sterile injectables (aseptic filling); tablets; ointments; liquids; sachets; intramammaries, penicillins, biopharmaceuticals, etc. The auditor will liaise with the CMO, perform the audit, write the audit report and follow up on corrective actions.

GMP Auditing of APIs, Raw Materials, Excipients, Medical Devices and Packaging Materials

We can supply lead auditors for GMP auditing of APIs, Raw Materials, Excipients, Medical Devices, and Packaging Materials who will liaise with the auditee, perform the audit, write the audit report and follow up on corrective actions.

GMP Auditing of CROs

We can supply lead auditors for GMP auditing of CROs and one of our specialities is the auditing of analytical laboratories and stability testing facilities.

CMC Documentation We have considerable experience in the preparation of CMC documentation for submission to regulatory authorities in the US, the EU, Japan, Canada, Australia and the ROW. Particular areas of expertise include: stability reports, stability summary reports, impurity reports, justification of specification reports and validation reports. We are able to prepare CMC documentation, or can review your own documents and advise on areas that may require revision before submission to the regulatory authority. Additionally, we can support clients in responding to authority questions during the submission and review phase.

Stability Report Writing

We have extensive experience in the preparation of stability reports for submission to regulatory authorities in the US, the EU, Japan, Canada, Australia and the ROW. One of our specialities is the preparation of stability reports for inhalation products.

Method Transfer

We can assist with the creation of method transfer plans and method transfer protocols. We can manage and monitor the method transfer to an external CRO and act as the first point of contact for your company. We can compile the final method transfer report and assess whether successful method transfer has been achieved.

Stability Testing

We have extensive experience in the outsourcing of stability testing to CROs and can manage and monitor the stability testing work undertaken by an external CRO. We will do this by means of regular telecons, face to face meetings and by maintaining excellent communication and rapport with the CRO.

Method Development

We can manage and monitor the method development work conducted at external CROs, based upon extensive experience with state-of-the-art analytical technologies.

Method Validation

We can write validation protocols for Phases I, II and III and monitor the validation work conducted at external CROs. We can compile the final validation report for IND, IMPD, NDA or EU regulatory submissions.

Selection of CROs

We have worked closely with a number of UK CROs and can advise on CRO selection and the best fit for your company's requirements.

Website last updated: 19th July 2016