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  • How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment
    How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment

    Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) will effect their products. However, under the new regulations, no medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.

  • An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles
    An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes, discussing the important aspects of those devices. In this part, we will examine the various aspects of prefilled syringes with staked-in needles and their impacts. We will conclude with some general thoughts on vendor selection for successful partnership.

  • ISO 22519: An Unnecessary, Faulty, And Confusing Standard
    ISO 22519: An Unnecessary, Faulty, And Confusing Standard

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

More From Pharma Contributing Editors

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  • Clinical Trial Packaging, Labeling And Storage In Horsham, UK

    This video provides insight into Thermo Fisher Scientific’s primary and secondary packaging of clinical trial materials at the Horsham, UK site. This site also specializes in automated global distribution and in Cold Chain Management.

  • Quick To Clinic™ for Oral Solid Dose

    In as little as 14 weeks from receiving your small molecule API, you can have your Phase I drug product manufactured, labelled, packaged and delivered to the clinic. That’s 1 month faster than most standard timelines, and includes a one-month stability study.

  • Kaleido Biosciences Successfully Meets Aggressive IND Filing Thanks To Strategic Partnership

    Designed specifically for new and emerging companies such as Kaleido Biosciences, The Quick to Care™ program is an integrated solution that combines drug substance and drug product development, clinical manufacturing, forecasting, demand planning and clinical trial supply execution managed by a single program manager.

More From Pharmaceutical Online Videos

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How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment

Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) will effect their products. However, under the new regulations, no medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.

An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles

This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes, discussing the important aspects of those devices. In this part, we will examine the various aspects of prefilled syringes with staked-in needles and their impacts. We will conclude with some general thoughts on vendor selection for successful partnership.

ISO 22519: An Unnecessary, Faulty, And Confusing Standard ISO 22519: An Unnecessary, Faulty, And Confusing Standard

The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility

The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. After the operating organization decides that leasing is the most economical approach, the search should focus on the technical merit of the property and the features it offers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.

More From Pharma Contributing Editors

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TITLE SUMMARY DISPLAY

  • How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment

    Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) will effect their products. However, under the new regulations, no medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.

  • An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes, discussing the important aspects of those devices. In this part, we will examine the various aspects of prefilled syringes with staked-in needles and their impacts. We will conclude with some general thoughts on vendor selection for successful partnership.

  • ISO 22519: An Unnecessary, Faulty, And Confusing Standard

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment

Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) will effect their products. However, under the new regulations, no medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.

An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles

This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes, discussing the important aspects of those devices. In this part, we will examine the various aspects of prefilled syringes with staked-in needles and their impacts. We will conclude with some general thoughts on vendor selection for successful partnership.

ISO 22519: An Unnecessary, Faulty, And Confusing Standard ISO 22519: An Unnecessary, Faulty, And Confusing Standard

The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

More From Pharma Contributing Editors