Regulatory

Breaking News

Calibre acquires lab supplier SciQuip

SciQuip is a leading laboratory supply company in the UK and offers a broad and diversified portfolio that includes product lines from centrifugation

Catalent enters commercial supply agreement

Since 2017, Harm Reduction Therapeutics has been working on a low-cost, OTC naloxone product to act as a critical tool to help stem the loss of life

Biggest overhaul of trial regulation for 20 years

A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners

European Commission adopts proposal to delay MDR deadlines

With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to m...

Stahl completes acquisition of ICP Industrial Solutions Group

ISG is primarily active in North America (close to 70% of sales), where it is a recognised technical leader

CatSci's new partnership with AGC Pharma Chemicals

AGC Pharma Chemicals have more than 40 years of small molecule CDMO and 60 years of API manufacturing experienc

Investment, outsourcing and globalisation: key trends for 2023

The start of 2023 has been challenging for the pharmaceutical industry. Economic constraints in Europe and the United States, staffing shortages, a...

From food to pharma: antioxidant scavengers as a viable strategy to mitigate nitrosamines in drugs

Stakeholders throughout the pharmaceutical value chain have had to deal with the recall of nitrosamine-containing medications, loss of revenue and,...

Almac completes “outstanding” grade by the KTP

The Innovate UK-funded KTP aimed to embed flow technologies to ensure long term security of supply for key raw materials through development

Thermo Fisher achieves ISO certification

Accreditation certificate number 6559.01 was granted by the American Association for Laboratory Accreditation (A2LA)

EU GMP Annex 1 (August 2022): impact on cleaning and disinfection

Cleaning and microbial contamination control are critical focus areas in the pharmaceutical and medical device industries. Robust cleaning and disi...

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

Synaffix expands licensing agreement with MacroGenics

The expansion comes just a year after the original February 2022 deal, increasing the total potential consideration by up to $2.2 billion

Why create a participation-based chemical safety culture?

With 1.7 million workers suffering from work-related ill health in 2020/21, a recent Health and Safety Executive (HSE) report showed that health is...

Pharmatech enters alliance with Integra Continuous Manufacturing

The partnership will provide a complete package of services and a proven roadmap for success to address the technical and experiential gaps

EU supply chain regulation: what will it mean for companies attending CPHI?

Ahead of her session on “Manufacturing Excellence” at CPHI Frankfurt (1–3 November), Elisabeth Stampa, President of Medicines for Europe, along wit...