Regulatory affairs

23 Results

Small Molecule development – getting it right

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

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

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

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

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...

Clear Guidelines for IND/CTA

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

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

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

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...

Validating The Simoa Technology

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...

How will Brexit affect the Pharmaceutical Industry?

How will Brexit affect the Pharmaceutical Industry?

Content provided by Source BioScience Ltd | 08-Mar-2018 | 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...

Elemental Impurities Regulations View from a CRO

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...

How Sponsors and CROs Benefit From EDC Efficiencies

How Sponsors and CROs Benefit From EDC Efficiencies

Content provided by Merge eClinical | 01-Apr-2015 | White Paper

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