thought leadership

AUGUST 22, 2024

Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. Let's dive into the complex world of GMP compliance , where rules are our friends, and audits are like surprise parties (the kind you actually want to attend). But fear not!

Compliance 94

Compliance 94

Perficient: Drug Development

NOVEMBER 14, 2023

Non-compliance with these regulations can result in hefty fines, as seen with Sephora’s recent $1.2 million penalty. The Growing Need for Consent Management The proliferation of privacy laws and regulations worldwide has led to a multitude of compliance deadlines.

Compliance 98

Compliance Regulations Production Marketing 98

thought leadership

JULY 25, 2023

In this post, we’re going to discuss the various types of GxP Compliance Audits, internal versus independent third-party audits.

Compliance 91

Compliance International 91

BioPharma Drive: Drug Pricing

JULY 3, 2023

iliomad Health Data can help you maintain GDPR compliance. What is the GDPR and why does it matter to your life sciences company.

Trials 246

Trials Compliance Science 246

Collaborative Drug

AUGUST 15, 2023

The CDD Vault SaaS platform empowers researchers to capture experimental data digitally, foster real-time collaboration, and ensure regulatory compliance. The ELN also facilitates the creation of standardized experiment protocols through templates, ensuring compliance and reproducibility.

Science 245

Science Research Compliance International 245

Collaborative Drug

AUGUST 15, 2023

The CDD Vault SaaS platform empowers researchers to capture experimental data digitally, foster real-time collaboration, and ensure regulatory compliance. The ELN also facilitates the creation of standardized experiment protocols through templates, ensuring compliance and reproducibility.

Science 240

Science Research Compliance International 240

Drug Patent Watch

DECEMBER 11, 2024

As the world grapples with the consequences of climate change, companies must adapt their operations to reduce environmental impacts while maintaining cost-effectiveness and regulatory compliance. Regulatory Compliance and Incentives Regulatory compliance is a critical aspect of sustainable generic drug development.

Drug Development 96

Drug Development Compliance Drugs Pharmaceuticals 96

Drug Patent Watch

DECEMBER 11, 2024

Regulatory Compliance and Quality Assurance Regulatory compliance and quality assurance are essential aspects of CDMO selection. Pharmaceutical companies should evaluate a CDMOs compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place.

Pharmaceutical Companies 96

Pharmaceutical Companies Compliance Pharmaceuticals Drug Development 96

Drug Patent Watch

DECEMBER 10, 2024

Enhanced Regulatory Compliance : Integrated CDMOs can provide comprehensive supervision over all research, development, and manufacturing initiatives, ensuring compliance with strict regulatory guidelines set by entities like the FDA and EMA.

Drug Development 87

Drug Development Compliance Pharmaceutical Companies Drugs 87

Collaborative Drug

NOVEMBER 20, 2024

Collaborative Drug Discovery has received SOC 2 Type II Attestation

Compliance 113

Compliance Drugs 113

DrugBank

OCTOBER 30, 2024

  Enhanced Security and Compliance In the pharmaceutical and healthcare industries, security is paramount. Snowflake ensures that DrugBank’s data packages meet the highest standards of security and compliance, giving you peace of mind when handling sensitive data.

Production 98

Production Clinical Trials Packaging Compliance 98

Quanticate

FEBRUARY 14, 2025

Learn how BIMO listings help sponsors and CROs navigate FDA inspections, ensuring clinical trial compliance and data accuracy.

Clinical Trials 64

Clinical Trials Compliance Trials FDA 64

thought leadership

APRIL 17, 2025

The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food and Drug Administration (FDA), is responsible for ensuring prescription drug advertising and promotional materials are:

Compliance 66

Compliance FDA Drugs Science 66

thought leadership

OCTOBER 9, 2024

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

Compliance 59

Compliance Therapies Marketing 59

BioPharma Drive: Drug Pricing

JUNE 20, 2024

RxPass, which fills prescriptions for generic drugs, is now available to more than 50 million Medicare members after Amazon brought it into compliance with the insurance program’s regulatory standards.

Compliance 157

Compliance Drugs 157

DS in Pharmatics

JANUARY 11, 2025

Regulatory compliance defines success in biopharmaceuticals and medical devices. Our expertise strengthens compliance strategies, mitigates issues, and boosts operational efficiency. Learn how quality and compliance consulting secures [] Learn how quality and compliance consulting secures []

Compliance 52

Compliance 52

Perficient: Drug Development

OCTOBER 9, 2024

Accessibility compliance in medical device software is more than a regulatory checkbox; it’s a strategic necessity that impacts user safety, market reach, and brand reputation. Partner with us to ensure your medical device software meets the highest standards of accessibility and compliance.

Compliance 52

Compliance FDA Engineering Production 52

BioPharma Drive: Drug Pricing

OCTOBER 2, 2023

It’s time to adopt open-source technology – but not without security, compliance and guardrails.

Science 157

Science Compliance 157

BioPharma Drive: Drug Pricing

DECEMBER 11, 2023

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

Science 157

Science Compliance Marketing Research 157

Drug Patent Watch

AUGUST 28, 2024

The EU’s Good Manufacturing Practice (GMP) guidelines provide the minimum standards for API manufacturing, and compliance with these guidelines is mandatory for all manufacturers and importers of APIs intended for the EU market.

Compliance 59

Compliance Pharmaceuticals Marketing 59

Fierce BioTech

APRIL 28, 2025

Accelerating Time-to-Market: Balancing Speed, Compliance, and Operational Excellence jpiatt Mon, 04/28/2025 - 14:42 Tue, 06/24/2025 - 10:00 Resource Type Webinar Promotion Start Thu, 05/01/2025 - 08:30 Promotion End Sat, 11/01/2025 - 08:30 In the highly competitive world of drug development, few things matter more than getting to market first.

Compliance 52

Compliance Marketing Drug Development Regulations 52

Perficient: Drug Development

DECEMBER 18, 2023

In the fast-paced realm of finance, the significance of regulatory risk and compliance management practices cannot be overstated. The Role of Regulatory Risk and Compliance 1. Compliance with these legal obligations is not only mandated by regulatory authorities but also necessary for maintaining an institution’s reputation.

Regulations 111

Regulations Compliance 111

Fierce BioTech

OCTOBER 15, 2024

A Pharma Marketers' Roadmap to Data Privacy Compliance : Are You Ready for 2025? As state laws continue to shape advertising practices, understanding the nuances of compliance and data ethics is crucial. As state laws continue to shape advertising practices, understanding the nuances of compliance and data ethics is crucial.

Compliance 52

Compliance Marketing Regulations 52

Perficient: Drug Development

MAY 14, 2025

Can you demonstrate robust security measures and regulatory compliance? Data security and compliance with regulations like HIPAA, GDPR, or PCI are likely critical requirements for your organization. Ask your vendor for clearly defined compliance certifications, and if they conduct regular security audits.

Compliance 52

Compliance Regulations Production 52

FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M.

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Compliance Production Government Packaging 59

Advarra

OCTOBER 22, 2024

The challenge of educating this new community involves the need to balance theoretical knowledge with practical experience, which enables them to ensure ethical compliance and adapt to evolving research methodologies. The post Educating New Researchers: Mastering Human Subjects Research and Ethical Compliance appeared first on Advarra.

Compliance 52

Compliance Research Regulations 52

Perficient: Drug Development

MARCH 25, 2025

Look for folks who: Actually understand the data (a rare breed, cherish them) Can handle details without going cross-eyed Won’t melt down when stuck between the rock of compliance and the hard place of IT Bonus: Give them a fancy title like “Data Integrity Czar.”

Government 52

Government Compliance Regulations 52

PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Advarra

NOVEMBER 14, 2024

Strengthened regulatory compliance: Different countries have varying regulatory requirements and expectations. This compliance is crucial for the successful regulatory approval and dissemination of trial results. A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards.

Clinical Trials 97

Clinical Trials Trials International Clinical Research 97

Perficient: Drug Development

FEBRUARY 12, 2025

This transformation will require a delicate balance between innovation and compliance, ensuring that advancements in AI contribute to a secure and efficient payments landscape. These changes require significant adjustments in risk management, compliance frameworks, and operational protocols.

Compliance 52

Compliance Regulations Production Government 52

thought leadership

APRIL 14, 2025

Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). A thorough understanding of these requirements can enhance operational efficiencies and reduce compliance costs for MAHs.

Compliance 52

Compliance Regulations Marketing Production 52

Perficient: Drug Development

NOVEMBER 20, 2024

Prioritize assets based on compliance requirements and risk levels. Observe Develop a complete inventory of cryptographic assets from both a network and application perspective. Analyze key exchange mechanisms like TLS and SSL to understand current vulnerabilities. Transform Transition to quantum-safe algorithms and encryption protocols.

Government 106

Government Compliance Research 106

FDA Law Blog: Biosimilars

JUNE 10, 2024

It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.

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FDA Compliance Laboratories International 111

Drug Patent Watch

MARCH 17, 2025

That's why it's essential to develop a well-thought-out strategy that takes into account factors such as market research, regulatory compliance, and marketing tactics. Regulatory compliance : Ensuring that all necessary approvals and certifications are in place before launching the product.

Compliance 56

Compliance Drugs Marketing Pharmaceuticals 56

Perficient: Drug Development

AUGUST 4, 2024

Improved Security and Compliance With stringent regulatory requirements in the financial sector, security and compliance are paramount. Regulatory Reporting and Compliance Automation Compliance reporting is often a resource-intensive process.

Compliance 110

Compliance Marketing Production 110

Perficient: Drug Development

JANUARY 6, 2025

Legal Compliance Many countries have regulations and laws that mandate accessibility in public services, including healthcare. Adopting braille and large print is not just a matter of best practice but also legal compliance, ensuring that healthcare providers meet the required standards for accessibility.

Compliance 52

Compliance Regulations Treatment Production 52

DS in Pharmatics

MARCH 3, 2025

Heres a quick overview: Together, these processes are essential for maintaining EU regulatory compliance, [] However, their similar names and overlapping functions can lead to confusion – particularly for those outside the EU/UK regulatory framework.

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Compliance Pharmaceuticals 52