Agency IQ

NOVEMBER 10, 2023

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency. Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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The Pharma Data

DECEMBER 28, 2020

Our new directors are well-recognized for their leadership and accomplishments in the biopharmaceutical, biotechnology and pharmaceutical industries, as well as in public capital markets and corporate governance.” ” The new directors are: Raphael (“Rafi”) Hofstein, Ph.D. Dr. Hofstein received his B.Sc.

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Agency IQ

JULY 7, 2023

What is the state of pharmaceutical quality in the U.S.? Call it murky A new report published by the FDA’s Office of Pharmaceutical Quality (OPQ) promises a look at the current “State of Pharmaceutical Quality.” Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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PPD

DECEMBER 19, 2023

While the FSP model is growing in popularity and serves a critical role in pharmaceutical development, getting the most out of this model requires dedicated roles to drive implementation, communications and planning. Read our white paper to learn the keys to successfully implementing functional service partnerships.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. As a leader in early phase development oncology trials, we are dedicated to using our vast experience to enhance the patient experience and successfully bring new therapies to market.

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The Pharma Data

JANUARY 6, 2021

… Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are growing at a rate of nearly eight percent annually. . DOWNLOAD TO LEARN MORE>>>> Source link.

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PPD

JULY 9, 2024

Biotech and biopharma companies, however, must do all of this in the face of wildly fluctuating workloads — particularly during the post-marketing phase. Download our white paper The post FSP Flex Hub Teams Maximize Efficiency Across Lifecycle Maintenance appeared first on PPD. Let’s connect.

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The Pharma Data

JANUARY 7, 2021

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).

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The Pharma Data

NOVEMBER 16, 2020

To ensure the safety, quality and efficacy of a drug product prior to market roll out, it is critical life sciences companies can uphold the integrity and security of the data generated throughout an entire product’s lifecycle. For further information on how we process and monitor your personal data click here.

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The Pharma Data

MARCH 20, 2021

Fermentation is used in the production of renewable feedstocks for food products and ingredients, beverages, pharmaceutical compounds, nutraceuticals, through to fine and bulk chemicals. The Kluyver Center applies microbial genomics to improve the performance of microorganisms in industrial fermentation processes.

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FDA Law Blog: Biosimilars

JANUARY 24, 2024

If this vision is achieved, the United States can bring innovative biotechnologies and products to markets faster while building a more robust supply chain ecosystem. generic pharmaceutical industry, resulting in low profit-margins. The first goal under Theme 1—Goal 1.1—is The cost of implementing these technologies must be addressed.

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Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions.

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Alta Sciences

OCTOBER 28, 2024

White Paper: Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ Discover how the Sinclair Nanopig™ is transforming nonclinical safety assessments. Read the white paper. Watch it now.

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PPD

NOVEMBER 18, 2024

However, in the modern biotech and pharmaceutical industry, a PV RI team needs to do more than just monitor ever-changing regulations. Given the multinational nature of many biotech and pharmaceutical companies, conducting business in multiple countries with multiple vendors is not uncommon.

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Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. no[r] a marketing product” under Lanham Act). Medicis Pharmaceutical Corp. , Leading Market Technologies, Inc. , Paragon 28, Inc.

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