Regulatory affairs

21 Results

Why should you use clinical trial technology?

Content provided by Formedix | 16-Oct-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape.

ReciBioPharm - An optimized Plasmid DNA platform to accelerate the path to clinic and commercialization

Recipharm AB | Recorded the 14-Sep-2023 | Webinar

Assessing key parameters of the upstream process to achieve high titer while maintaining desired integrity
Customizing the downstream process to...

Small Molecule development – getting it right

Content provided by Lonza Small Molecules | 20-Jun-2023 | Insight Guide

Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...

A Guide Through the API Drug Development Pipeline

Content provided by Lonza Small Molecules | 04-Apr-2023 | Insight Guide

With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...

The Complete Guide to eRegulatory and eSource

Content provided by Florence Healthcare | 01-Apr-2023 | Insight Guide

Shifting to eRegulatory and eSource workflows is a requirement for clinical trial sites to continue to scale and grow their studies. This guide is designed...

How clinical trial software can optimize trials

Content provided by Formedix | 20-Jun-2022 | White Paper

Companies often have to conduct multiple clinical trials at the same time, which means they've got to be efficient, and compliant with industry regulations....

Strategic Approach to Immunogenicity Assessment

Content provided by Altasciences | 17-May-2022 | 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...

Psychedelics and Entactogens: Challenges Associated with Schedule I Therapeutic Development

Content provided by Altasciences | 18-Mar-2022 | White Paper

Under the Controlled Substances Act (CSA) in the United States, drugs that have the potential to be abused are scheduled into one of five Classes or Schedules...

Clear Guidelines for IND/CTA

Content provided by Altasciences | 24-Feb-2022 | White Paper

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

Using SDTM, ADaM, and SEND

Content provided by Formedix | 20-Dec-2021 | White Paper

This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how...

Automating clinical trials for success

Content provided by Formedix | 06-Oct-2021 | 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

Content provided by PerkinElmer | 14-Jul-2021 | White Paper

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

Global Pediatric Drug Development Collaboration: Part Two

Content provided by PRA Health Sciences | 09-Jul-2020 | White Paper

70% of medicines given to children have never been studied in pediatric populations. Children who need treatments represent a relatively small population....

Global Pediatric Drug Development Collaboration: Part One

Content provided by PRA Health Sciences | 09-Jul-2020 | White Paper

The pharmaceutical industry is unlike any other industry in that the products manufactured can dramatically improve, and even save, lives. This is especially...

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Content provided by Frontage Laboratories | 01-Dec-2019 | White Paper

Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed,...

How to Avoid Surprises in Small-Molecule Drug Development Programs

Content provided by Frontage Laboratories | 01-Oct-2019 | 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

Content provided by Frontage Laboratories | 01-Oct-2019 | White Paper

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

The Truth about Physician Referrals and Clinical Trials

Content provided by BBK Worldwide | 24-Jul-2019 | 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

Content provided by 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...

Elemental Impurities Regulations View from a CRO

Content provided by RSSL | 02-Nov-2016 | White Paper

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

The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing

Merck KGaA, Darmstadt, Germany | Recorded the 09-Apr-2015 | Webinar

Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard...