ACTO

DECEMBER 17, 2024

Part 2 Our first blog covered the ABCs of Artificial Intelligence (AI) and AIs evolution. The stakes for AI adoption in the pharmaceutical industry have never been higher. This post discusses key issues pharma executives must consider to ensure responsible, compliant, and successful AI implementation within their organizations.

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Alta Sciences

JANUARY 31, 2025

Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting pmjackson Fri, 01/31/2025 - 15:47 Ria Falvo, Director of Reporting, and Rina Massarelli, Associate Director of Safety Reporting, in Toronto, Ontario, for the 2024 STC Symposium.

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Perficient: Drug Development

APRIL 17, 2025

This blog series celebrates Perficients recognition as a 2025 USA Today Top Workplace. In our last blog, we discussed how Perficient is Shattering Boundaries through our global delivery model and cutting-edge strategies. By building strong relationships , we develop customized solutions that go above and beyond their expectations.

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thought leadership

AUGUST 14, 2024

One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. This blog explains the three elements required for developing a successful regulatory strategy.

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The Premier Consulting Blog

NOVEMBER 6, 2024

The combination of different active pharmaceutical ingredients (APIs), each with distinct physical and chemical properties, along with the need for precise, efficient drug delivery to the lungs, requires careful CMC planning and execution.

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Collaborative Drug

JUNE 21, 2024

Burlingame, CA, June 21, 2024 — Collaborative Drug Discovery (CDD), a leading provider of data management solutions for the pharmaceutical and biotechnology industries, is pleased to announce the integration of iChemLabs' industry-leading IUPAC naming technologies into CDD Vault.

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

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FDA Law Blog: Biosimilars

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Last week, OPQ released its 6th Annual Report on the State of Pharmaceutical Quality. to maintain its gold standard of pharmaceutical quality. By Kalie E.

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DS in Pharmatics

MAY 23, 2024

Could you please introduce yourself and your expertise in the pharmaceutical industry? In this interview, NewsMedical talks to Dr. James Mencel’s Guidanceabout Scaling Up API Processes. I earned a Bachelor of Science in Chemistry at Fairfield University in 1979 and a Ph.D. in Organic Chemistry at Yale University in 1984 […]

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The Premier Consulting Blog

APRIL 13, 2025

4] ICH = International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 6] ICH Harmonised Guideline M7(R2) (2023): Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. link] [7] H.R.2565

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ACTO

AUGUST 30, 2023

The technique has proven to be especially effective in addressing the unique barriers that adult learners often encounter, particularly while learning dense and complex material, such as that in pharmaceutical sales training. This blog will explore how gamification is positively impacting pharmaceutical sales training.

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The Premier Consulting Blog

AUGUST 21, 2024

Phase-appropriate information and data to support CMC content, such as specifications, analytical methods, analytical method validation, pharmaceutical development, and stability, should be developed as clinical development progresses. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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The Connected Lab

OCTOBER 6, 2021

This blog dissects the anatomy of effective digital infrastructure, and how these component technologies can be used in combination to realize the benefits offered by Pharma 4.0. The post Pharmaceutical System Thinking and Digital Infrastructure: Seeking Inspiration in Human Cognition appeared first on The Connected Lab.

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC. 23-5200 (D.C.

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Translation

AUGUST 31, 2023

Person symbol Claudia Lang The New Zealand Institute for Plant and Food Research The post Bayer Crop Science 2023 Grants4Ag Awardees appeared first on Translation | Halo Blog. Black icon.

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The Premier Consulting Blog

APRIL 3, 2024

Part 2 of this blog series includes a more in-depth discussion on analytical procedure control strategy, and the benefits of the enhanced approach in the lifecycle management and post-approval changes of analytical procedures. Pharmaceutical Development Q8(R2). ICH Harmonised Guideline. Analytical Procedure Development Q14.

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Alta Sciences

NOVEMBER 4, 2024

Case Study: How to Ensure Safety While Manufacturing Highly Potent APIs aasimakopoulos Mon, 11/04/2024 - 17:37 Highly potent active pharmaceutical ingredients (API) require careful attention to safety and handling during formulation and manufacturing.

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DS in Pharmatics

OCTOBER 23, 2024

Quality, safety, and efficacy are core tenets of pharmaceutical manufacturing. Our blog aims to elucidate the nuances of QP certification and batch release within the European Union (EU), […] One critical component of this assurance process is batch release.

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BenchSci

SEPTEMBER 19, 2024

As pharmaceutical research and development (R&D) continues to evolve at a rapid pace, AI assistants—software powered by artificial intelligence (AI) that responds to inquiries in human-like text or voice—hold the promise of significantly enhancing efficiency.

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DS in Pharmatics

MARCH 3, 2025

Qualified person (QP) certification and declaration are distinct in their objectives within pharmaceutical and biotech industries. However, their similar names and overlapping functions can lead to confusion – particularly for those outside the EU/UK regulatory framework.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

Godwin provided updated information on the presentation made the day before by another CDER official, Jennifer Maguire, the Director of the Office of Quality Surveillance within the Office of Pharmaceutical Quality at CDER, We summarized in a blog post yesterday her comments about facilities with FDA inspections that had been classified as Official (..)

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DS in Pharmatics

JUNE 12, 2024

Date: June 12, 2024 Location: San Diego, CA ProductLife Group (PLG), a leading provider of product development and compliance services in the pharmaceutical and biotechnological sectors, is excited to announce a comprehensive solution aimed at transforming the landscape of drug development, underscoring PLG's commitment to advancing healthcare through (..)

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thought leadership

MAY 3, 2024

In the highly regulated pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is paramount. This blog aims to shed light on the importance of EU/UK QP audits, examining key elements such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Annex 16.

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DS in Pharmatics

JANUARY 16, 2024

The pharmaceutical industry is growing through global collaboration and market expansion. To continue this growth, regulatory compliance for Chemistry, Manufacturing and Controls (CMC) must be followed. Without CMC regulatory compliance, the safety behind the creation of any products could be compromised.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

(HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico.

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DS in Pharmatics

JULY 7, 2023

As a supply chain expert in the biotech and pharmaceutical industry, I understand the unique challenges faced by companies operating in this highly regulated and complex sector.

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FDA Law Blog: Biosimilars

JUNE 27, 2023

Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. Karst was named by Who’s Who Legal: Life Sciences 2023 as one of only 14 “Global Elite Thought Leaders.”

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DrugBank

APRIL 25, 2024

As the pharmaceutical industry is pushing to deliver new and better drugs while racing against time and budget constraints, it is becoming crucial to not just use artificial intelligence (AI) but truly maximize its potential. Invest in Your Tech Infrastructure A solid tech foundation is essential for AI to work in the pharmaceutical sector.

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Drug Patent Watch

FEBRUARY 26, 2025

Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments. In our latest blog post, we dive into the strategies and challenges of patenting drug combinations.

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FDA Law Blog: Biosimilars

AUGUST 8, 2023

Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy.

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FDA Law Blog: Biosimilars

APRIL 16, 2024

Vanda Pharmaceuticals, Inc. Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. We previously blogged on the district court’s decision last year. Vanda Pharmaceuticals, Inc.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. By John W.M.

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Pharmaceutical Development Group

FEBRUARY 1, 2022

The seamless use of the electronic submission process also requires proactive and early compliance with Pharmaceutical Product and Process Science-Risk Based Characterization Principles. The opinions and statements in this blog are those of the authors and do not necessarily reflect those of PDG. Spanogle, Ph.D.

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DS in Pharmatics

FEBRUARY 9, 2024

In the realm of pharmaceuticals, data integrity stands as a cornerstone, underpinning the veracity of scientific research, the efficacy of drug development, and the safety of patient outcomes.

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FDA Law Blog: Drug Discovery

JANUARY 2, 2023

Comprehend the structure of FDA and the roles of the three major agency centers: CDER, CBER and CDHR, master the basics of the application and approval processes for drugs and biologics, gain a practical working knowledge of clinical trial process for pharmaceutical products and much more!

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Pharmaceutical Development Group

DECEMBER 19, 2021

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products that improve the quality of life for their patients. In a FDA Pre-Submission that leads to FDA Approval, more does not equal better and more does not equal relevance to a specific Pharmaceutical Drug or Biologic Product.

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FDA Law Blog: Biosimilars

JULY 24, 2024

Each fall, leading pharmaceutical patent litigators for brand-name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments affecting Hatch-Waxman litigation and participate in significant peer-to-peer networking opportunities.

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