NGS is changing GxP compliance. Will you adapt?
BioPharma Drive: Drug Pricing
MARCH 17, 2025
Discover NGS for GxP compliance with full audit trails, operational control and robust data security.
Compliance Related Topics 
In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm
FDA Law Blog: Biosimilars
FEBRUARY 26, 2025
Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. So, yes, compliance and quality still matter, a lot. By John W.M. How will the cuts at FDA impact inspections and enforcement?
Compliance 
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Easy GxP compliance for NGS data – is it even possible?
BioPharma Drive: Drug Pricing
SEPTEMBER 16, 2024
NGS is changing the landscape for GxP compliance. How can you adapt?
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What is GxP Compliance: A Detective’s Guide to Quality and Regulatory Compliance
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.
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Staying GMP Compliant: A Consultant's Guide to Compliance Bliss
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!
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Consent Management for Compliance and Customer Experience Benefits
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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What You Need to Know About GxP Independent Compliance Audits, Part 1
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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What US trial sponsors should know about the GDPR
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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CDD Recognized in 2023 Gartner® Life Science Discovery Research
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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CDD Recognized in 2023 Gartner® Hype Cycle™ for Life Science Discovery Research
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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The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing
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.
How to Develop a Sustainable Generic Drug Development Strategy
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.
CDMO Selection: The Ultimate Checklist
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.
Collaborative Drug Discovery Receives SOC 2 Type II Compliance Attestation
Collaborative Drug
NOVEMBER 20, 2024
Collaborative Drug Discovery has received SOC 2 Type II Attestation
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BIMO Listings in Clinical Trials: Ensuring Compliance & Data Integrity
Quanticate
FEBRUARY 14, 2025
Learn how BIMO listings help sponsors and CROs navigate FDA inspections, ensuring clinical trial compliance and data accuracy.
ProPharma Honored with 2024 CPHI Regulatory and Compliance Award
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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How Quality Assurance Consulting Helps Prevent Compliance Issues
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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Amazon expands drug subscription program to Medicare members
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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7 Steps to Define a Data Governance Structure for a Mid-Sized Bank (Without Losing Your Mind)
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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Accessibility Compliance in Medical Device Software: A Strategic Imperative
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.
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Product Highlight: DrugBank on Snowflake Marketplace
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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Ready for open source in life sciences? Your pharma analytics journey might be
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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Regulatory Considerations for API Manufacturing in the EU: Ensuring Compliance and Supply Chain Resilience
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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Life sciences leaders invest in process mining to accelerate digital transformation
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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6 Reasons Financial Institutions Are Embracing Risk and Regulation Tactics
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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A Pharma Marketers' Roadmap to Data Privacy Compliance : Are You Ready for 2025?
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.
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Enhancing Animal Health Compliance & Comprehensive MI and PV Services
thought leadership
SEPTEMBER 23, 2024
Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and quality of their animal health products.
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ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition
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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Educating New Researchers: Mastering Human Subjects Research and Ethical Compliance
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.
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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law Blog: Biosimilars
JULY 7, 2024
The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § Merely providing links to existing MDR training materials for traditional device manufacturers, as the new compliance guide does, fails to meet FDA’s stated objective.
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The Real Cost of Complexity: What Every Drug Developer Needs to Know
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.
The Power of Worldwide Networks in Data and Safety Monitoring Boards
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.
How to Implement a Successful Generic Drug Launch Strategy
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.
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Quantum Computing and Cybersecurity: Preparing for a Quantum-Safe Future
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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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections
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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How to Manage Generic Drug Development Timelines: Strategies for Success
Drug Patent Watch
FEBRUARY 12, 2025
Collaboration with Regulatory Experts : Working with regulatory experts who have in-depth knowledge of the generic drug development process can help you navigate the complex regulatory landscape and ensure compliance with all relevant regulations.
Unlocking the Power of Azure Integration Services for the Financial Services Industry
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.
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Universal Design for Visual Disabilities in Healthcare – Braille and Large Print – 11
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.
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What Pharma Must Know About Responsible AI Implementation
ACTO
DECEMBER 17, 2024
These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders. a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.
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5 Major Benefits of Azure Integration Services Over MuleSoft
Perficient: Drug Development
AUGUST 12, 2024
Enhanced Security and Compliance Security and compliance are top priorities for any integration platform. Azure Integration Services benefits from Azure’s robust security features and compliance certifications.
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Medical Coding in Clinical Data Management
Quanticate
SEPTEMBER 30, 2024
In any clinical trial conduct, recording and storing data in a controlled, consistent, and reproducible manner for data retrieval and analysis is a necessity for regulatory compliance and clinical study success.
ACI’s 3rd Annual Forum on Advanced Therapeutics
FDA Law Blog: Drug Discovery
MARCH 3, 2025
From funding innovations and AI in drug discovery to navigating legal and compliance challenges, this conference will provide you with the opportunity to gain the insights you need to drive scientific advancements to global market success. Hyman, Phelps & McNamara, P.C.s FDA Law Blog is a conference media partner.
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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research
Advarra
AUGUST 8, 2024
We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026.
Two technology-based approaches that improved hand hygiene compliance are featured at infection prevention conference
SCIENMAG: Medicine & Health
JUNE 26, 2023
Orlando, Fla., June 27, 2023 – Hand hygiene is the simplest, most effective way to prevent the spread of infections in healthcare, yet healthcare worker adherence is often low.
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