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Featured companies in Regulatory

CARBOGEN AMCIS

CARBOGEN AMCIS is a global Contract Development and Manufacturing Organisation (CDMO) providing drug development and commercialisation services to the pharmaceutical and...

PCI Pharma Services

PCI Pharma Services: Your bridge between life-changing therapies and patients.

NSF

Founded in 1944, NSF’s mission is to protect and improve global human health. NSF, Pharmaceutical Services provides a comprehensive range of independent, third-party...

Abzena (San Diego) Inc

Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or...

Hermes Pharma GmbH

HERMES PHARMA is the leading expert in developing and manufacturing user-friendly oral dosage forms. As a CDMO, we offer customized services along the entire pharmaceutical...

Trending Articles

  1. Teva wins FDA approval for once-monthly olanzapine injection The US approval of WELTRUZA, developed using Medincell’s controlled-release technology, introduces a long-acting subcutaneous formulation for adults with schizophrenia that...
  2. FDA Form 483 explained: responding to findings and managing regulatory risk Explore what a Form FDA 483 means, how to respond within 15 business days, assess patient risk, address observations and understand how FDA evaluates responses and inspection...
  3. FDA inspection readiness: Preparing for surveillance and pre-approval inspections Preparing pharma and biotech teams for continuous FDA inspection readiness, mock inspections and proactive regulatory risk management
  4. Why staying connected matters for today’s qualified persons Helen explains how the NSF QP Alumni community helps Qualified Persons stay current through regulatory updates, peer discussions and shared experience, offering practical...
  5. Leica Biosystems brings Tempus pathology products to Aperio AI Store Expanding the Aperio AI Store gives researchers more ways to study cancer through AI-enabled tools within a connected digital pathology ecosystem

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Ingredients Resonant Clinical Solutions – a global clinical solutions partner serving life sciences organisations across the clinical supply chain and sample lifecycle – and Haier...
Resonant clinical solutions and Haier Biomedical introduce an innovative Benchtop centrifuge with a nantural refrigerant

Resonant clinical solutions and Haier Biomedical introduce an innovative Benchtop centrifuge with a nantural refrigerant

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Manufacturing Vetter’s Norbert Gerling discusses operational challenges, flexible manufacturing, automation and contamination control in sterile drug production
Navigating complexity in aseptic fill and finish

Navigating complexity in aseptic fill and finish

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Regulatory With the right questions and scrutiny during procurement, organisations can avoid the over-engineering trap and select a QMS solution that fits their requirements and allows...
The cost of complexity: why mid-tier manufacturers need to rethink regulatory technology strategy (part I)

The cost of complexity: why mid-tier manufacturers need to rethink regulatory technology strategy (part I)

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Regulatory The US approval of WELTRUZA, developed using Medincell’s controlled-release technology, introduces a long-acting subcutaneous formulation for adults with schizophrenia that...
Teva wins FDA approval for once-monthly olanzapine injection

Teva wins FDA approval for once-monthly olanzapine injection

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Regulatory Pharma equipment supplier Syntegon is taking automated contamination control technologies and expert advice directly to manufacturers and CDMOs across Europe, with its Annex 1...
Syntegon launches European Annex 1 compliance roadshow

Syntegon launches European Annex 1 compliance roadshow

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Regulatory The UK's advertising watchdog has ruled against several companies advertising oral GLP-1 weight loss medications to the UK public, working with the MHRA to ensure compliance...
ASA bans first weight loss pill ads

ASA bans first weight loss pill ads

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Regulatory Learn why early notified-body engagement is critical for combination products, including design rationale, risk controls, validation evidence and traceable documentation ahead...
Why early notified-body engagement matters for combination product success (VIDEO)

Why early notified-body engagement matters for combination product success (VIDEO)

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Regulatory Helen explains how the NSF QP Alumni community helps Qualified Persons stay current through regulatory updates, peer discussions and shared experience, offering practical...
Why staying connected matters for today’s qualified persons

Why staying connected matters for today’s qualified persons

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Manufacturing Preparing pharma and biotech teams for continuous FDA inspection readiness, mock inspections and proactive regulatory risk management
FDA inspection readiness: Preparing for surveillance and pre-approval inspections

FDA inspection readiness: Preparing for surveillance and pre-approval inspections

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Manufacturing Explore what a Form FDA 483 means, how to respond within 15 business days, assess patient risk, address observations and understand how FDA evaluates responses and inspection...
FDA Form 483 explained: responding to findings and managing regulatory risk

FDA Form 483 explained: responding to findings and managing regulatory risk

Read more
Regulatory Expanding the Aperio AI Store gives researchers more ways to study cancer through AI-enabled tools within a connected digital pathology ecosystem
Leica Biosystems brings Tempus pathology products to Aperio AI Store

Leica Biosystems brings Tempus pathology products to Aperio AI Store

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Manufacturing New automated distillation analysers combine reliable measurement performance, robust long-term operation and connected workflows for modern petroleum and petrochemical testing...
Anton Paar’s new Diana series brings robust engineering to automated distillation

Anton Paar’s new Diana series brings robust engineering to automated distillation

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Manufacturing Aenova Latina's paired oRABS and isolator filling lines give flexible, scalable sterile manufacturing, from clinical to commercial batches, guided by contamination control...
Aseptic processing by design

Aseptic processing by design

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Regulatory The agency has cited serious CGMP deficiencies at Fresenius Kabi’s Melrose Park facility, including failures involving aseptic processing, investigations, bioburden controls...
FDA warns Fresenius Kabi over sterile manufacturing violations

FDA warns Fresenius Kabi over sterile manufacturing violations

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Training & Education Manufacturing, biotech and pharmaceutical, and education organisations represent the top industries for CLM adoption. Their operations involve complex supplier networks,...
What industries benefit most from contract lifecycle management solutions?

What industries benefit most from contract lifecycle management solutions?

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Regulatory Pinsent Masons data shows 936 filings in the year to March 2026 — spanning oral formulations, method-of-use patents for conditions including cancer and Parkinson's and...
GLP-1 patent applications surge 146% in five years as semaglutide cliff drives evergreening and biosimilar race

GLP-1 patent applications surge 146% in five years as semaglutide cliff drives evergreening and biosimilar race

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