Blog: Medical and Pharmaceutical

Borderline Cosmetics in the EU
19 September 2023

Borderline Cosmetics in the EU

Understanding a product's classification for regulatory compliance More…

Driving compliance and transparency in pharma supply chains
13 September 2022

Driving compliance and transparency in pharma supply chains

Why the alignment of audit scope with the correct industry standard is important More…

Reflecting on Remote Supplier Audits
31 August 2021

Reflecting on Remote Supplier Audits

Helping the pharma industry maintain focus on quality More…

New Standard for Vaccine Storage Units
Market drivers for electronics in a COVID-19 world
Mask Assessments 101
17 November 2020

Mask Assessments 101

A Guide to Requirements for Face Coverings More…

Pharmaceutical stability contingency and disaster recovery
16 June 2020

Pharmaceutical stability contingency and disaster recovery

Mitigating the risks in pharmaceutical stability storage More…

Why Did My Part Break?
The Bridge to China
26 November 2019

The Bridge to China

Medical Device Approvals with the National Medical Products Administration (NMPA) More…

Biomarker Discovery, Technical Qualification and Validation
The Keys to Success
20 November 2018

The Keys to Success

Outsourcing Stability Studies to Contract Laboratories More…

Bioanalysis and Immunogenicity Series - Volume 4
30 October 2018

Bioanalysis and Immunogenicity Series - Volume 4

Biosimilar Pharmacokinetic and Immunogenicity Method Development and Validation More…

Bioanalysis and Immunogenicity Series - Volume 3
Bioanalysis and Immunogenicity Series - Volume 2
04 September 2018

Bioanalysis and Immunogenicity Series - Volume 2

Using Innovative and Non-Conventional Techniques to Address Bioanalytical Challenges More…

Bioanalysis and Immunogenicity Series - Volume 1
Fuel Cell Technologies - An External Supply of Chemical Energy
Mitigating Risks in Pharmaceutical Stability Storage
06 December 2016

Mitigating Risks in Pharmaceutical Stability Storage

Stability studies represent considerable investment in cost and time. What steps can be taken to mitigate the risks of losing valuable samples in storage due to unforeseen disasters? More…

Not all rubber is made equal!
05 July 2016

Not all rubber is made equal!

A discussion on risk assessments of leachables from medical device components More…

Ensuring Safe and Stable Inhaled Medicines
26 April 2016

Ensuring Safe and Stable Inhaled Medicines

Stability studies play an important role in inhalation drug development More…

Establishing Health-Based Exposure Limits for Active Pharmaceutical Ingredients
Betting the Pharm: Determining Regulatory Expectations for Pharmacology Studies
02 June 2015

Betting the Pharm: Determining Regulatory Expectations for Pharmacology Studies

Are you generating sufficient pharmacology data and presenting the data effectively for your preclinical drug development program? More…

Risky Business: Toxicological Risk Assessments to Support Product Safety
20 January 2015

Risky Business: Toxicological Risk Assessments to Support Product Safety

Extractables, leachables, impurities, degradants, contaminants – what else can go wrong? More…

Making Sense of the RoHS2 Directive for Medical Devices
10 February 2014

Making Sense of the RoHS2 Directive for Medical Devices

Learn more today about non-electrical items and if they are included in the RoHS2 directive. More…

Update: RoHS 2 Deadline for July 22, 2014
08 January 2014

Update: RoHS 2 Deadline for July 22, 2014

When is RoHS 2 compliance required for declaration of CE Mark? More…

A Closer Look: Medical Devices Used in the Home
03 December 2013

A Closer Look: Medical Devices Used in the Home

What are the challenges the home environment can present when related to medical devices? More…

Ensuring Safety and Essential Performance: Medical Devices Used in the Home
18 November 2013

Ensuring Safety and Essential Performance: Medical Devices Used in the Home

Medical devices used for home healthcare are designed to specifically to ensure safety. More…

 
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