The Premier Consulting Blog

NOVEMBER 6, 2024

Improved convenience and patient compliance: ICPs can offer improved convenience for patients by requiring only one device, rather than two or more separate inhalers – ultimately resulting in better patient compliance. However, these products present unique challenges from a Chemistry, Manufacturing, and Controls (CMC) standpoint.

Production

The Pharma Data

JUNE 24, 2025

By combining USP’s rigorously characterized reference materials with Bio-Techne’s user-friendly, high-resolution analytical instruments, the collaboration intends to streamline workflows, improve data accuracy, and enable greater compliance with global regulatory expectations. Senior Vice President of Global Biologics at USP. Source link

Therapies

FDA Law Blog: Biosimilars

JULY 23, 2025

Pete’s in-depth knowledge of FDA’s internal processes and priorities enhances his ability to advise pharmaceutical, biotech, and other FDA-regulated companies on regulatory compliance, product development, and enforcement risk. He also provides strategic litigation support and proactive counsel on agency engagement.

Government

Drug Target Review

JULY 7, 2025

2 This ethical spotlight has practical implications for research institutions and sponsors, including the need for more robust justification protocols, heightened compliance measures and increased risk of reputational harm or funding loss. iPSC-cardiomyocytes in the preclinical prediction of candidate pharmaceutical toxicity.

Drug Research

ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

Government

Drug Patent Watch

FEBRUARY 12, 2025

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development.

Drug Development

The Premier Consulting Blog

DECEMBER 10, 2024

Key components of the CMC section The CMC section of an NDA contains detailed information on the following aspects of the investigational drug: Drug substance or active pharmaceutical ingredient (API). Compliance with good manufacturing practices (GMP). Complying with global regulations. Managing risk is critical.

Marketing

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.

Engineering

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. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.

Drug Development

Drug Patent Watch

JANUARY 9, 2025

The pharmaceutical landscape is evolving rapidly, with small and medium-sized biotech companies increasingly taking center stage in innovation. Managing Quality and Compliance Quality and regulatory compliance are non-negotiable in pharmaceutical manufacturing. How can you ensure your CDMO is up to scratch?

Compliance

Advarra

DECEMBER 17, 2024

As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. Continued harmonization will not only ease the regulatory burden but also facilitate faster study initiation and improve compliance.

Clinical Research

Drug Target Review

JUNE 18, 2025

Long timelines, strict regulation and scientific uncertainty are part of the job. However, when that pressure is compounded by political shifts, market volatility and rising expectations from the global pharmaceutical industry, the old ways of working start to crack. In early-stage drug discovery, pressure is nothing new.

Drugs

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. Risk Mitigation CDMOs help mitigate risks associated with regulatory compliance by ensuring that products meet the required standards.

Compliance

Drug Channels

JULY 21, 2025

State Dispute Resolution Meetings where you'll participate in targeted discussions between manufacturers and states to resolve rebates, reporting, and compliance questions. The MDRP Summit remains essential for anyone navigating the complex intersection of pharmaceutical economics, compliance, and government programs.

Government

Drug Target Review

MAY 26, 2025

Daniel Galbraith, Chief Scientific Officer at Solvias , brings extensive expertise in the pharmaceutical and biotechnology sectors. In his role, he provides both strategic and technical guidance to Solvias, a global Contract Research Organisation (CRO) that offers critical analytical services to the pharmaceutical industry.

Drug Development

PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. It may also lead to decreased patient retention, which may result in significant delays to trial completion or loss of statistical power.

Clinical Trials

Advarra

MARCH 6, 2025

Over the years, Advarra has reviewed a wide range of clinical research studies and worked every day alongside leading pharmaceutical manufacturers, medical researchers, and healthcare institutions. Industry-Leading Ethical Standards Advarra is organized and operates in compliance with U.S.

Clinical Research

The Pharma Data

JUNE 6, 2025

Global Pharmaceutical Contract Sales Outsourcing Market to Reach $24.8 Billion by 2030: Strategic Insights, Regional Trends, and Technological Shifts Reshaping the Landscape The global pharmaceutical contract sales outsourcing (CSO) market is entering a transformative phase, with its value expected to grow from $17.3

Pharmaceutical Companies

Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. But what exactly does Quality Assurance entail?

Drugs

Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. This not only helps to ensure compliance, but also fosters a culture of trust and cooperation within the industry.

Compliance

Drug Patent Watch

MARCH 24, 2025

Navigating the Complex World of CDMO Contracts: What to Look Out For As a pharmaceutical professional, you're likely no stranger to the importance of finding the right Contract Development and Manufacturing Organization (CDMO) partner. Regulatory Compliance Regulatory compliance is a top priority in the pharmaceutical industry.

Compliance

Drug Patent Watch

FEBRUARY 20, 2025

The Unseen Heroes of the Pharmaceutical Industry: Achieving High-Quality Standards in Generic Drugs As we navigate the complex world of healthcare, it's easy to overlook the unsung heroes who work tirelessly behind the scenes to bring affordable, high-quality medications to the masses.

Drugs

thought leadership

SEPTEMBER 12, 2024

Introduction In the brightly lit corridors, clean rooms, and warehouses of pharmaceutical and medical device industries, a mystery lurks—a puzzle shrouded in regulations, veiled in risk, and cloaked in the shadows of compliance.

Compliance

H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game.

Compliance

ProRelix Research

APRIL 17, 2025

Indiaprovidesanidealsettingforsuchcost-savingstrategiesduetoseveralkeyfactors: Economic Benefits Conducting trials in India can reduce costs by up to 60%comparedtoWesterncountries.Labor costs,participantrecruitment,hospitalinfrastructure,andadministrativefeesaresignificantly lower. […] The post Outsourcing Clinical Trials to India: Global Regulation, (..)

Clinical Trials

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. a synthetic control arm)?

Clinical Research

Fierce BioTech

FEBRUARY 12, 2025

Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement. Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement.

Regulations

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.

Clinical Trials

thought leadership

APRIL 4, 2025

Pharmaceutical tariffs of 25% have been forecasted causing many global organizations to investigate the consequences of the tariffs on their overall product portfolio. The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy.

Pharmaceuticals

Advarra

DECEMBER 14, 2023

b)) Categorized within the investigational plan regulations, there is a specific emphasis on accurate and complete documentation of all trial activities. This enables higher levels of training compliance over the course of study conduct, as well as the necessary understanding of trial activities to perform the right task at the right time.

Compliance

thought leadership

SEPTEMBER 9, 2024

On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following documentation.

Pharmaceuticals

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.

Pharmaceuticals

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023 ( DOJ Press Release ). Consent Agreement and Final Judgment ¶ 10.a.-n.

Pharmacy

Drug Channels

SEPTEMBER 13, 2021

Thought-leaders and colleagues from federal agencies, bio/pharma manufacturers, consultants, industry trade associations and law firms will gather to discuss key insights on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices.

Compliance

FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

Compliance

thought leadership

OCTOBER 23, 2023

In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices , and other regulatory requirements is paramount.

Compliance

thought leadership

MAY 8, 2024

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking registration and market access in the European Union (EU) for their products.

Pharmaceutical Companies