The Premier Consulting Blog

DECEMBER 10, 2024

Validation involves detailed documentation of every step of the production process, from raw material sourcing to final product packaging in good manufacturing practice (GMP) compliant facilities. Detailed documentation and reporting of batch testing results are essential components of NDA submission. Complying with global regulations.

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Advarra

JULY 3, 2025

While the latest revision marks progress in advancing transparency and scientific rigor, it also demands a thorough reassessment of research practices to ensure adherence to new regulations. Patient consent: Do your consent documents meet patients’ language and literacy needs across media formats (text, visuals, video)?

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PPD

FEBRUARY 10, 2025

By harnessing the full range of innovative technologies and taking advantage of an FSP partners extensive skills and experience, sponsors are able to bring their therapies to market more quickly and within budget even in the face of complicated global regulations and widely fluctuating workloads.

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PPD

JANUARY 2, 2025

Pharmacovigilance (PV) : A premier FSP PV partner provides expertise to monitor global regulations, analyze and interpret them in the context of a biotechs specific needs, communicate regulatory requirements, and implement solutions to support the sponsors internal capabilities.

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PPD

DECEMBER 16, 2024

Each region presents its own set of unique and complex regulations that must be met, creating a daunting landscape for companies striving to bring their therapies to market. Although adhering to complex regulations may initially complicate trials, it serves as a critical safeguard against future roadblocks.

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Alta Sciences

NOVEMBER 15, 2024

Specify your short-term objectives, such as starting a new trial phase, submitting additional regulatory documents, or expanding into new regions, along with your long-term goals. It’s also important to ask about their past interactions with regulators, including inspections and their outcomes. IND, CTA, NDA, BLA). “If

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Codon

APRIL 17, 2025

Still, despite the genus first being documented in 1839, the broader scientific community had been unaware of its capacity for mimicry. Such vascular differences are governed by auxin, a plant hormone that regulates leaf venation and shape. Nobody yet knows. A parasitic plant called Cuscuta pentagona , found throughout the U.S.

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The Pharma Data

JUNE 15, 2025

Infections were documented in 18 patients (58% of the study population), with 5 cases (16%) classified as serious; none resulted in a grade 5 event (death related to the study treatment).

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DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

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FDA Law Blog: Biosimilars

JANUARY 9, 2025

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection. FD&C Act 501(j).

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Advarra

DECEMBER 17, 2024

AI can also automate labor-intensive tasks, such as extracting key information from protocol documents to populate downstream systems. As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners.

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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

This condition was included in the final rule for the original regulations, 21 CFR 314 Subpart H (see the December 11, 1992 Federal Register, 57 FR 58958 ) as well as when the pathway was codified in the Federal Food, Drug, and Cosmetic Act by FDAMA (21 USC 356(c)) in 1997.

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PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. It automates repetitive tasks such as documentation, summarization and annotation — significantly improving efficiency.

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Alta Sciences

NOVEMBER 4, 2024

Product Disposal: We disposed of all waste and material generated from the manufacturing loteprednol etabonate at regulated chemical treatment facilities. Proper documentation and disposal protocols ensured compliance with environmental and safety standards.

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Perficient: Drug Development

JANUARY 30, 2025

Regulations like the General Data Protection Regulation (GDPR) in the EU, the California Consumer Privacy Act (CCPA) in California, and other global privacy laws mandate that businesses protect the privacy of individuals and ensure their data is stored and processed securely.

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Conversations in Drug Development Trends

NOVEMBER 12, 2024

The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Perficient: Drug Development

FEBRUARY 26, 2025

Especially if the site is sizable in both page count and number of assets, such as documents and images. From business goals and priorities, page views, conversion rate, SEO considerations and marketing campaigns, to compliance and regulations. Migrating your site to a different platform can be a daunting prospect.

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The Pharma Data

JUNE 20, 2025

While effective at suppressing inflammation, long-term corticosteroid use comes with a host of well-documented side effects—particularly concerning in the elderly—such as osteoporosis, diabetes, hypertension, infections, and adrenal suppression. For many years, systemic corticosteroids have been the mainstay of BP treatment. Dr. George D.

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Perficient: Drug Development

NOVEMBER 6, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles.

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thought leadership

JUNE 30, 2025

The EU Clinical Trial Regulation (CTR) (No. In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the integrity of the research process.

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Perficient: Drug Development

MAY 28, 2025

Yet, amidst this intoxicating surge of innovation, a sobering reality looms large: the absence of robust, globally harmonized frameworks for responsible development and stringent regulation. Imagine a model trained on a dataset containing confidential company documents or private medical records.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

How regulators will interpret and enforce its provisions may not become clear for some time. By integrating modern trial methodologies and technologies, it provides a framework for conducting clinical research more efficiently while maintaining the highest standards of ethics, data integrity, and patient safety.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

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FDA Law Blog: Biosimilars

APRIL 10, 2025

As it relates to the FDA, FOIA serves as a vital tool for stakeholders including patients, researchers, and regulated industry to better understand the Agencys scientific, policy and regulatory decision-making. However, not all information contained in FDA records is disclosable.

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Advarra

MARCH 7, 2025

The Vital Role of Institutional Review Boards (IRBs) As set forth in the federal regulations that govern the conduct of clinical trials, an IRB is an independent group of experts, including scientists and non-scientists, that reviews clinical trial proposals to ensure they meet ethical standards that are designed to protect participants rights.

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FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

Therefore, this guidance builds on FDAs commitment to develop and apply innovative approaches to the regulation of [AI-enabled devices]. Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026.

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FDA Law Blog: Biosimilars

APRIL 22, 2025

If you decide to request a hearing, DEAs revised hearing regulations require that you simultaneously file an Answer to the Order to Show Cause. DEAs Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents.

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Science Daily: Pharmacology News

AUGUST 12, 2024

New findings document fewer ship tracks, reduced cloud cover, and boosted warming after ship emissions regulations took effect in 2020.

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BioPharma Drive: Drug Pricing

JANUARY 23, 2025

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.

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PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

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Agency IQ

MARCH 25, 2024

BY COREY JASEPH, MS, RAC With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

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Regulations 59

BioPharma Drive: Drug Pricing

AUGUST 14, 2023

The regulator has asked for documents tied to the 2021 deal as well as to the conduct and compensation of Illumina and Grail management.

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Regulations 130

Agency IQ

JULY 22, 2024

BY WALKER LIVINGSTON, ESQ On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Regulations 59

Agency IQ

JANUARY 4, 2024

In a long-anticipated draft report, the FDA has offered a vision for a series of potential improvements to the way it currently publishes guidance documents. Fill out the form to read the full article.

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FDA Regulations 59

Agency IQ

JULY 12, 2024

BY ALEXANDER GAFFNEY, MS, RAC The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond.

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Perficient: Drug Development

JANUARY 19, 2024

One use case organizations can consider is Synthetic Data and Document Generation, which allows companies to automate the creation of synthetic (or fake) data for testing purposes, therefore accelerating their digital transformation initiatives. What Is Synthetic Data and Document Generation?

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