Regulatory affairs

14 Sep 2023 Thursday

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

Recipharm AB | Webinar

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

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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...

Covance Touchless Drug and Device Vigilance Vision

Content provided by 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...

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...

Parents as Gatekeepers for Children with Cancer

Content provided by PRA Health Sciences | 08-Jun-2020 | 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

Content provided by PRA Health Sciences | 04-May-2020 | 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,...

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...

Assessing Pre-Existing Antibodies in Biotheraputic Development

Content provided by Frontage Laboratories | 21-Aug-2019 | 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

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...

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...

The Power to Make, A Virtual Tour

Content provided by 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

Content provided by pharmasol | 20-Mar-2017 | 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

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...

Excellence in Pharmaceutical Analysis

Content provided by 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

Content provided by World Courier | 22-Mar-2016 | 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

Content provided by Sciformix | 08-Mar-2016 | 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...

The World is Changing, Talk to Marken

Content provided by Marken | 05-Nov-2015 | 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...

7 Common Myths about QP Training Debunked - A Guide for Senior Managers

Content provided by RSSL | 14-Oct-2015 | White Paper

The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law. Every holder of a relevant Manufacturers Authorisation (human...

Tailor-made solutions for the healthcare industry

Content provided by B. Braun Melsungen AG | 29-Sep-2015 | White Paper

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

Discover the benefits of collaborating with your central lab partner early in protocol development

Content provided by ACM Global Central Laboratory | 19-May-2015 | Clinical Study

Until recently, sponsors and CROs engaged their central laboratory simply for routine safety testing. However, as clinical trial protocols have grown in...

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

Content provided by QPS | 07-May-2015 | 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

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...

Global Ethics - what you need to ensure integrity

Content provided by World Courier | 16-Mar-2015 | 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...

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...

There are a number of ways Recipharm protects you.

Content provided by Recipharm AB | 02-Mar-2015 | Case Study

Our serialisation process can help prevent reimbursement fraud, theft, the delivery of counterfeited medicines and more. Read our case study to learn how...

Meaningful Metrics – A CMO Perspective

Content provided by Patheon Inc | 05-Jan-2015 | White Paper

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

Things are “heating up” in temp-controlled shipping

Content provided by World Courier | 24-Nov-2014 | White Paper

The BRIC nations will account for $248 billion in pharmaceutical Sales by 2016. Global Pharma will spend $8 billion on cold chain logistics in 2014 These...

Customized drug application kits

Content provided by B. Braun Melsungen AG | 02-Oct-2014 | 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...

New Guidelines Strengthen Good Distribution Practice (GDP)

Content provided by RSSL | 18-Sep-2014 | White Paper

The recently introduced EU Guidelines on the Good Distribution Practice of Medicinal Products for Human Use, (first published on March 8th 2013 as 2013/C...

Viral-Challenge Studies: Regulatory Requirements

Content provided by SGS Life Science Services | 15-Sep-2014 | 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...

Turning “Oh No” into “No Problem”

Content provided by World Courier | 15-Sep-2014 | 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,...

7 Common Myths about QP Training Debunked : A Guide for Senior Managers

Content provided by Reading Scientific Services Limited | 11-Sep-2014 | White Paper

The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK...

Analysis of Biopharmaceuticals to Conform to ICHQ6B

Content provided by RSSL | 24-Jul-2014 | White Paper

Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by...

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

Content provided by RSSL | 19-Jun-2014 | White Paper

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical...

Learn the risk factors of metabolic syndrome and the role central labs play in aiding its detection

Content provided by ACM Global Central Laboratory | 17-Jun-2014 | Clinical Study

Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected...

Customs Warehouses Benefit Clinical Trial Supply Chain

Content provided by Marken | 11-Jun-2014 | White Paper

Marken’s new customs-bonded warehouse within the Marken depot in Frankfurt, Germany allows Marken to store pharmaceuticals with an origin outside the European...

Are there Any Markets left to Emerge?

Content provided by World Courier | 02-Jun-2014 | 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...