Prior to the introduction of the EU Clinical Trials Directive in May 2004, there was no regulatory requirement for sites running Phase I healthy volunteer clinical trials to have any formal inspection
Pharmaceutical Profiles has received an important 'vote of confidence' from the Medicines and Healthcare products Regulatory Agency (MHRA) with the announcement that it has been awarded compliance certificates for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
Pharmaceutical Profiles is a specialist early clinical CRO and claims to be a world leader in the conduct of human drug absorption (HDA) studies that determine the complex oral biopharmaceutical properties of new molecular entities and help guide the life-cycle management of marketed products.
These studies provide a 'route map' to subsequent clinical development by demonstrating whether a product is suitable for oral delivery, if it will require enabling technologies to keep it in development, or if it is a poor drug candidate where further development should be stopped.
The company also offers sophisticated pharmacoscintigraphy studies and human microdosing studies.
Prior to the introduction of the European Union Clinical Trials Directive in May 2004, there was no regulatory requirement for sites running Phase I healthy volunteer clinical trials to have any formal inspection.
Under the rules of the Directive, however, compliance with regulatory guidelines became a legal requirement.
In addition, processes were formalised allowing governmental regulatory bodies to inspect clinical and manufacturing sites.
"The GCP and GMP compliance certificates will give any client, existing or potential, a high level of reassurance that we have been thoroughly inspected by the MHRA and our systems and facilities meet the required standards to conduct Phase I clinical trails," explained Pharmaceutical Profiles's chief operating officer Simon Lee.
"It is excellent news for the company and our clients and follows a year when we have made more than 30 successful CTA submissions on behalf of our pharmaceutical industry clients - which speaks volumes in itself about our high standards." Pharmaceutical Profiles is headquartered in Ruddington, near Nottingham, UK, in a modern, purpose-built facility containing a clinical research facility, GMP manufacturing facilities and research laboratories.
It also has representative offices in the USA and Japan.
