QP Services

With a strong team of QPs, Penn supports clinical and commercial pharmaceutical projects, including assistance to companies wishing to import medicinal products and devices into the EU.

At Penn we believe flexibility is imperative. That’s why you can choose to use our highly effective QP service in support of all our development services or as a ‘stand-alone’ consultancy. This has been particularly useful for our customers located in Japan, USA and Australasia, including assistance to API manufacturers and purchasers needing to meet the requirements of the EU API directive 2004/27/EC.

With several resident QPs available 24/7 who are conversant with the latest EU regulations, clients are assured of expert and rapid QP Services that cover pharmaceuticals and medical devices for clinical and commercial use.

We:

• Conduct familiarisation audits for our customers prior to EU importation and provide supporting reports
• Provide European testing facilities and Qualified Person release for non-EU products (PharmacEUtical Portal™)
• Offer initial diagnostic services to determine importation parameters and interpretation of the EU legislation in relation to our client’s development programmes
• Review Clinical Trial Applications
• Have several QPs on site all the time performing routine releases in accordance with documentation described in technical agreements