Bioequivalence services

Generic Drug Development…Unique Partnering Needs

Our sponsors developing generic products have anything but generic needs. At PAREXEL we have developed a deep understanding of the unique requirements of generics, having decades of experience in partnering with diverse generic product development companies of all sizes.

Developing with Confidence

With increasing public demand for generic products, there is great pressure on the development timelines for generic companies. There are benefits to being the first to market and PAREXEL helps our clients complete their clinical development sooner and with confidence. Working with a leading global partner like PAREXEL – a company known for high quality and expertise – gives you assurance that your studies will benefit from world class expertise, superior resources and importantly, provide you confidence that you will be well equipped for market application. With the benefit of experience across the entire development continuum, and having played a role in the development of 45 of the top 50 pharmaceutical products on the market, PAREXEL can be relied upon to perfectly complement your own resources – no matter how large or small your company – to position you for success.

On Time…On Budget

PAREXEL Early Phase provides tailored solutions for clients large and small. We understand that many of our generics clients have tight budgets and timelines and we have created a dedicated bioequivalence center to meet these needs. Our clinical unit in Bloemfontein, South Africa has more than 30 years experience in performing bioequivalence. The Bloemfontein unit is a PAREXEL center of excellence for performing bioequivalence studies and is strategically placed in the perfect location for these trials – a lower cost and fast start-up environment. Typically studies at this location can start within 4 weeks of regulatory submission and have the added advantage of an earlier start within the ‘Bolar provision.’

The unit provides over 170 beds, with additional capacity available through PAREXEL’s other units in South Africa (George and Port Elizabeth), operating as one site. Additionally the Bloemfontein unit has an on-site Bioanalytical laboratory, providing  access to over 500 pre-validated assay methods, and offering the convenience of a single partnership.

Bioequivalence Experience in Patient Populations

All of the units within our global network have experience in performing Bioequivalence (BE) studies in healthy volunteers. Several of the units provide specialized in-patient BE development services. With ready access to more than 70 patient populations through our own in-house patient databases, we provide one of the fastest one-stop solutions for clients developing products where testing in healthy volunteers is not possible. For example, the PAREXEL early phase units have recent experience in performing BE trials in Oncology populations and CNS populations such as schizophrenia.