Regulatory affairs

88 Results

How to Avoid Surprises in Small-Molecule Drug Development Programs

Frontage Laboratories | 01-Oct-2019 | Technical / White Paper

Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent...

Validating The Simoa Technology

Frontage Laboratories | 01-Oct-2019 | Technical / White Paper

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...

Assessing Pre-Existing Antibodies in Biotheraputic Development

Frontage Laboratories | 21-Aug-2019 | Technical / White Paper

Immunogenicity is the leading reason that biologics fail in clinical trials, and thus it has become imperative for drug development programs to include...

The Truth about Physician Referrals and Clinical Trials

BBK Worldwide | 24-Jul-2019 | Technical / White Paper

Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their...

Survey Report: State of the global pharmaceutical contract services industry 2018

William Reed | 11-Jul-2018 | Research Study

In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of...

The Impact of Contraceptive Requirements on Pediatric Clinical Trials

PRA Health Sciences | 17-May-2018 | Technical / White Paper

PRA’s whitepaper The Impact of Contraceptive Requirements on Pediatric Clinical Trials considers sponsors responsibilities in navigating the complex logistical...

How will Brexit affect the Pharmaceutical Industry?

Source BioScience Ltd | 08-Mar-2018 | Technical / White Paper

Have you prepared your strategy for the outcome of Brexit to ensure that you can continue to supply the UK market?
Source BioScience is a CRO with...

The Power to Make, A Virtual Tour

Althea | 24-Mar-2017

You have the power to make a difference. To make new therapeutics that improve quality of life and inspire a healthier world. To do this, you need a manufacturing...

psiXchange - Innovating SUSAR Distribution

pharmasol | 20-Mar-2017 | Technical / White Paper

A controlled document distribution process, in which getting the right information to the intended recipients within a required time frame and being able...

Elemental Impurities Regulations View from a CRO

RSSL | 02-Nov-2016 | Technical / White Paper

Regulatory control of elemental impurities in pharmaceutical products has long been discussed, with both the European Pharmacopeia (EP) and the United...