ProRelix Research

MAY 13, 2025

Once perceived as a regulatory gray zone, the Indian clinical research ecosystem has […] The post A Closer Look at Compliance and Regulations for Drug Clinical Trials in India appeared first on ProRelix Research. The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades.

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Clinical Trials Compliance Regulations Trials 52

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.

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Compliance Regulations Production Marketing 98

Perficient: Drug Development

MARCH 27, 2025

Our Databricks Practice holds FinOps as a core architectural tenet, but sometimes compliance overrules cost savings. There is a catch once we consider data deletion within the context of regulatory compliance. However; in regulated industries, their default implementation may introduce compliance risks that must be addressed.

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Compliance Regulations Government International 64

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.

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Compliance International 91

Drug Patent Watch

MARCH 26, 2025

In our latest blog post, we delve into the compliance hurdles that generic drug developers face, and the valuable lessons learned from these experiences. This not only helps to ensure compliance, but also fosters a culture of trust and cooperation within the industry. Share your experiences with us in the comments below!

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Compliance Drug Development Drugs Clinical Trials 52

Fierce BioTech

JUNE 11, 2025

Utilizing AI-Powered Structured Content Authoring for Global ePI Compliance Learn how to streamline ePI compliance with AI-powered tools and meet global mandates—essential insights for regulatory and content leaders. Download this whitepaper today.

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Compliance Marketing 52

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.

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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.

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Science Research Compliance International 245

Perficient: Drug Development

FEBRUARY 11, 2025

ADA Compliance Overview ADA compliance ensures websites are accessible to people with disabilities, promoting inclusivity and fairness. Ensuring clear focus visibility is key for accessibility; sometimes, visually impaired users and keyboard navigators have trouble interacting with web content. By following the WCAG 2.0

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Compliance Trials Marketing 52

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.

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Science Research Compliance International 240

Perficient: Drug Development

MAY 22, 2025

Every blog post, product update, or social post is a potential compliance risk if not handled carefully. For many firms, keeping up with compliance while managing complex content workflows feels like juggling chainsaws. Legal, Compliance, Risk, and other teams are deeply involved in every asset. All tracked. All compliant.

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Compliance Marketing Government Production 52

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.

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Drug Development Compliance Drugs Pharmaceuticals 93

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.

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Pharmaceutical Companies Pharmaceuticals Compliance Drug Development 94

Drug Patent Watch

DECEMBER 10, 2024

Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy. Risk Mitigation CDMOs help mitigate risks associated with regulatory compliance by ensuring that products meet the required standards. Societal CDMO. link] UPM Pharmaceuticals.

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Compliance Pharmaceuticals Pharmaceutical Companies Regulations 94

Collaborative Drug

NOVEMBER 20, 2024

Collaborative Drug Discovery has received SOC 2 Type II Attestation

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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.

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Production Clinical Trials Packaging Compliance 98

ProRelix Research

MAY 10, 2025

Herbal clinical trials in […] The post Essential Compliance Checklist for Regulations on Herbal Clinical Trials in USA appeared first on ProRelix Research. With the increasing popularity of herbal products for both preventive care and therapeutic intervention, the demand for rigorous scientific validation is stronger than ever.

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Clinical Trials Compliance Regulations Trials 52

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.

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Drug Development Compliance Drugs Pharmaceutical Companies 83

Quanticate

FEBRUARY 14, 2025

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

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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:

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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.

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Compliance Therapies Marketing 59

thought leadership

DECEMBER 9, 2024

Additionally, as regulators worldwide adopt more rigorous data integrity and compliance requirements, scrutiny of quality systems has intensified. Alongside these innovations, global supply chains have expanded, requiring manufacturers to coordinate with international partners, each subject to unique regulatory standards.

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Science Compliance Regulations FDA 75

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 []

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Compliance 52

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.

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Compliance Drugs 152

BioPharma Drive: Drug Pricing

OCTOBER 2, 2023

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

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Science Compliance 152

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.

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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.

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Compliance Marketing Drug Development Regulations 52

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.

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Science Compliance Marketing Research 152

FDA Law Blog: Biosimilars

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.

Compliance 59

Compliance Packaging Regulations FDA 59

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.

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Regulations Compliance 111

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.”

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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.

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Drug Development Clinical Trials Compliance Trials 52

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. Most of FDAs reviewers are exempt, while compliance, policy, and administrative support are typically furloughed. What does it mean for FDA staff?

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Government Compliance FDA Licensing 76

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.

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Government Compliance Research 106