Regulatory

Evonetix granted patent for DNA data storage tech

The company’s DNA-on-chip platform uses individually controlled ‘virtual wells’ to enable either de-novo DNA synthesis or immobilisation of pre-synthesised DNA for storage in-situ

Breaking News

BIA responds to NICE methods and processes review

Going forward, the BIA will continue to work with NICE as it implements these changes to its manual

A complete guide to the US DSCSA

Below, CosmoTrace provides a guide to the incoming regulatory changes around drug traceability for 2023

Yokogawa publishes industry report on data integrity challenges

The industry <a href='https://cp.yokogawa.com/Pharmaceutical_Manufacturing_Report.html'>report</a> details principles of good data management in th...

Packaging clause in new EU Clinical Trials Regulation is cause for great concern

Annex VI: the challenge of unintended consequences in the EU Clinical Trials Regulation

Aizon launches GxP compliant data aggregation solution

The system, Aizon Unify, has been designed to provided a compliant digital platform for monitoring, analysis and optimisation of all stages in the...

Vetter recognised with Global Customer Value Leadership Award

The Frost and Sullivan decision process involved three major steps

Nitrosamine testing: the regulatory aspects

Subsequent to the detection of nitrosamines in pharmaceuticals in 2018, this class of impurities has been a pressing topic in the pharmaceutical wo...

The new regulatory world for medical devices

Establishing an effective compliance strategy now ahead of the 2022 IVDR legislation is critical — because there’s more to come

Provepharm obtains FDA approval to supply APIs in the US

The development follows recent authorisation from the ANSM to provide active ingredients in European countries

Concept Life Sciences achieves MHRA GMP accreditation

The accreditation comes after a 2.5-year period of investment, during which the company created its facility and brought together a team specialisi...

Why Bayesian statistics is revolutionising pharmaceutical decision making

PharmaLex's Bruno Boulanger, Global Head of Statistics and Data Science, and Brad Carlin, Senior Adviser for Statistics and Data Science, explore t...

Deciding on a chemistry, manufacturing and control strategy for biologic development

Khanh Ngo Courtney from Avomeen discusses what biopharmaceutical companies should keep in mind as they embark on their CMC journey

SOTIO expands ADC pipeline with LegoChem agreement

The deal includes LCB’s conjugation technology, ConjuAll, and potent linker-payload platform

Developments in global pharmaceutical excipients in the next 3–5 years: part II

Key themes that will shape the excipient landscape in the near future will include regulations, innovation, economics and sustainability, says Dr I...

Kappa Bioscience renames analytical subsidiary

The sister company, previously known as Synthetica, will now be called Kappa Solutions

Developments in global pharmaceutical excipients in the next 3–5 years: part I

Key themes that will shape the excipient landscape in the near future will include regulations, innovation, economics and sustainability, says Dr I...