Regulatory affairs

97 Results

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Formedix | 20-Jun-2022 | Technical / White Paper

This article explains the different types of clinical trial software available, and how it can be used to optimize the end to end clinical trials design...

Strategic Approach to Immunogenicity Assessment

Strategic Approach to Immunogenicity Assessment

Altasciences | 17-May-2022 | Technical / White Paper

In this issue of The Altascientist we provide a detailed overview on the different goals and challenges that are presented by the validation of immunogenicity...

Clear Guidelines for IND/CTA

Clear Guidelines for IND/CTA

Altasciences | 24-Feb-2022 | Technical / White Paper

There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful...

Automating clinical trials for success

Automating clinical trials for success

Formedix | 06-Oct-2021 | Technical / White Paper

This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.

Empowering Clinical Trial Sponsors with Analytics

Empowering Clinical Trial Sponsors with Analytics

PerkinElmer | 14-Jul-2021 | Technical / White Paper

Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco...

Covance Touchless Drug and Device Vigilance Vision

Covance Touchless Drug and Device Vigilance Vision

Covance Patient Safety | 01-Sep-2020 | Data Sheet

Automation tools enable organizations to identify patterns in structured and unstructured data and facilitate automation of the entire product vigilance...

Parents as Gatekeepers for Children with Cancer

Parents as Gatekeepers for Children with Cancer

PRA Health Sciences | 08-Jun-2020 | Technical / White Paper

The RACE for Children Act will require new drugs intended for adult cancer treatment to also be studied in pediatric cancers when the molecular target...

RACE Act Prompts Pediatric Oncology Trials

RACE Act Prompts Pediatric Oncology Trials

PRA Health Sciences | 04-May-2020 | Technical / White Paper

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response,...

Validating The Simoa Technology

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...

How will Brexit affect the Pharmaceutical Industry?

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...

Ajinomoto-logo

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...

psi

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

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...

Excellence in Pharmaceutical Analysis

Excellence in Pharmaceutical Analysis

Butterworth | 16-Sep-2016 | Data Sheet

Butterworth specialise in Quality Control Analysis, Method Development, Validation & Stability Testing of Raw Materials, API, Finished Product and...

Orphan Drugs make all the difference to patients

Orphan Drugs make all the difference to patients

World Courier | 22-Mar-2016 | Technical / White Paper

Orphan drugs, those medications that are typically produced in small quantities for limited patient populations, are growing in importance worldwide. Once...

Can patient-centric innovation transform PV

Can patient-centric innovation transform PV

Sciformix | 08-Mar-2016 | Technical / White Paper

The importance of Pharmacovigilance (PV) as a science and its role in effective patient care in clinical practice and public health is growing. Patient-centeredness...

marken

The World is Changing, Talk to Marken

Marken | 05-Nov-2015 | Technical / White Paper

The landscape of the clinical trial supply chain is changing throughout the world. Patient centricities and immune, cell and gene therapies are now the...

Tailor-made solutions for the healthcare industry

Tailor-made solutions for the healthcare industry

B. Braun Melsungen AG | 29-Sep-2015 | Technical / White Paper

B. Braun OEM offers standard products or customized versions. Even the standard range contains hundreds of product versions, with which countless applications...

Seeking Drug Approval via the 505(b)(2) NDA Option

Seeking Drug Approval via the 505(b)(2) NDA Option

QPS | 07-May-2015 | Technical / White Paper

Today, many pharmaceutical companies are choosing the 505(b)(2) New Drug Approval (NDA) regulatory pathway. The 505(b)(2) NDA route relies on investigations...

How Sponsors and CROs Benefit From EDC Efficiencies

How Sponsors and CROs Benefit From EDC Efficiencies

Merge eClinical | 01-Apr-2015 | Technical / White Paper

Intense competition in the prescription drug market is driving pharmaceutical companies to expedite their drug discovery and development processes. Pharmaceutical...

Global Ethics - what you need to ensure integrity

Global Ethics - what you need to ensure integrity

World Courier | 16-Mar-2015 | Technical / White Paper

In a recent World Courier survey, 35% of respondents said that they were aware of bribery in their industries. This may have been acceptable in the past...

Meaningful Metrics – A CMO Perspective

Meaningful Metrics – A CMO Perspective

Patheon Inc | 05-Jan-2015 | Technical / White Paper

Learn about the roles of sponsors and their contract manufacturing organization (CMO) partners regarding metrics, what metrics to measure, how to manage...

Customized drug application kits

Customized drug application kits

B. Braun Melsungen AG | 02-Oct-2014 | Technical / White Paper

To avoid medication errors, application sets become more and more important for the pharmaceutical industry. These sets help to guarantee a safe and exact...

Turning “Oh No” into “No Problem”

Turning “Oh No” into “No Problem”

World Courier | 15-Sep-2014 | Technical / White Paper

With all that’s going on in the world right now it’s vital for us all to have plans in place to deal with the unexpected. We need to be prepared individually,...

Viral-Challenge Studies: Regulatory Requirements

Viral-Challenge Studies: Regulatory Requirements

SGS Life Science Services | 15-Sep-2014 | Technical / White Paper

The use of viral-challenge studies as POC studies is gaining wider acceptance. This approach accelerates the selection of a safe and effective dose and...

Are there Any Markets left to Emerge?

Are there Any Markets left to Emerge?

World Courier | 02-Jun-2014 | Technical / White Paper

North America, Western Europe and—to a lesser extent—Australasia once served as prime locations for the majority of research. But these Western markets...

Shipping with Active Packaging Containers

Shipping with Active Packaging Containers

World Courier | 22-Apr-2014 | Technical / White Paper

It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees....

Suppliers

Follow us

Product Innovations