Blog: Medical and Pharmaceutical
Borderline Cosmetics in the EU
Understanding a product's classification for regulatory compliance More…
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
Helping the pharma industry maintain focus on quality More…
New Standard for Vaccine Storage Units
Electrical Safety and Performance Considerations More…
Market drivers for electronics in a COVID-19 world
Considerations and innovations in hygiene, health & safety More…
Mask Assessments 101
A Guide to Requirements for Face Coverings More…
Pharmaceutical stability contingency and disaster recovery
Mitigating the risks in pharmaceutical stability storage More…
Why Did My Part Break?
A Look at the Failure Analysis and Investigation Process More…
The Bridge to China
Medical Device Approvals with the National Medical Products Administration (NMPA) More…
Biomarker Discovery, Technical Qualification and Validation
Using LBA, LC-MS and HRAMS Assay Formats More…
The Keys to Success
Outsourcing Stability Studies to Contract Laboratories More…
Bioanalysis and Immunogenicity Series - Volume 4
Biosimilar Pharmacokinetic and Immunogenicity Method Development and Validation More…
Bioanalysis and Immunogenicity Series - Volume 3
Technologies for Measurement: A Case Study More…
Bioanalysis and Immunogenicity Series - Volume 2
Using Innovative and Non-Conventional Techniques to Address Bioanalytical Challenges More…
Bioanalysis and Immunogenicity Series - Volume 1
FDA Expectations Regarding Immunogenicity Testing More…
Fuel Cell Technologies - An External Supply of Chemical Energy
Generating Electricity from an Electrochemical Reaction More…
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!
A discussion on risk assessments of leachables from medical device components More…
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
Are your manufacturing standards in line with the new EMA guideline? More…
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
Extractables, leachables, impurities, degradants, contaminants – what else can go wrong? More…
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
When is RoHS 2 compliance required for declaration of CE Mark? More…
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
Medical devices used for home healthcare are designed to specifically to ensure safety. More…