Penn Pharmaceutical Services - Outsourced, Integrated Pharmaceutical Development Solutions

Penn Pharmaceutical Services Ltd is a leading provider of outsourced, integrated pharmaceutical development services. The company provides a fully comprehensive drug development service which includes formulation and analytical development, the manufacture, packing and distribution of clinical trial supplies, custom manufacture, CMC consultancy and QP (Qualified Person) release services to the international healthcare community.

DRUG DEVELOPMENT SERVICES

Penn has over 25 years' industry experience. We provide flexible pharmaceutical solutions enabling our customers to accelerate their products, route-to-market quickly, safely and cost effectively. With the added advantage of all of our services being on one FDA and MHRA inspected site, all procedures are professionally managed and maintained to the highest worldwide standards.

Penn has also developed strategic alliances to expand our drug development capabilities. These alliances have enabled our clients to access additional services such as pre-clinical services, regulatory approval for labels and a network of distribution depots. As with Penn’s core services, these services can be used individually or as part of a multi-disciplined project.

ANALYTICAL SUPPORT AND DEVELOPMENT

Penn provides peace of mind by providing analytical support for a wide variety of product development programmes. Our clients range from small companies with specific development needs to multi-nationals requiring turnkey stability programmes for commercial batches.

Working to ICH and cGMP standards, our analytical development service can develop and validate analytical methodologies, supply analytical method transfer protocols and offer a wide variety of techniques including HPLC, Mass Spec, GC and LCMS. Penn can also offer cytotoxic and teratogenic compound testing.

DOSAGE FORMS, DEVICES AND DELIVERY SYSTEMS

Penn’s formulation team has vast experience in dealing with novel dosage forms, devices and delivery systems. We have specialist knowledge of film and enteric coating and can offer a variety of dosage forms for reconstitution including:

• Tablets
• Capsules
• Powders
• Gels and creams
• Liquids
• Solutions
• Suspensions and emulsions
• Suppositories and pessaries
• Granules

CLINICAL TRIAL SUPPLY

Supporting all your clinical trial supply needs from phase I to phase IV, we offer professional and cost-effective solutions. Our CTS group can manage the process from manufacturing through to returns and destruction. We can also offer blinding of study materials and comparators, and versatile labelling and assembly options.

We can also source comparators both in and outside of the UK, handle controlled/scheduled drugs, and provide temperature controlled storage under ambient, refrigerated and frozen conditions and cold chain shipment solutions. Working closely with our QP team, Penn is a gateway for all non-EU based companies planning to carry out clinical trials in Europe.

Penn’s Fast Track Phase 1 service is delivered by a self contained team responsible for managing Phase I and other small scale CTS projects. This enables Penn to provide our clients with an accelerated route to clinic, efficiently and more cost effectively without compromising regulatory compliance.

CUSTOM MANUFACTURE OF DOSAGE FORMS AND DEVICES

Complementing our formulation development and CTS services, Penn offers a high-quality custom manufacture service for a wide range of dosage forms and devices. Validation and scale up of manufacturing processes and our vast experience enable us to offer bespoke packing and distribution services. Penn’s manufacturing processes adhere to MHRA and FDA inspection standards.

In addition to our custom manufacturing service, Penn holds a specials manufacturing license which enables us to manufacture specialist, difficult and small volume products including named patient and compassionate supplies.

QP RELEASE SERVICES

Continuing our flexible philosophy, Penn’s highly effective QP release services can be used as a stand alone service or in support of all our development services. This has been particularly successful for our customers located in Japan, USA and Australasia. Penn has six resident QPs, and can offer:

• Familiarisation audits for clients prior to EU importation and supporting reports
• Provide European testing facilities and QP release for non-EU products
• Diagnostic services and interpretation of EU legislation for client importation into EU
• Review clinical trial applications