Drug Patent Watch

DECEMBER 30, 2024

Manufacturing and Quality Control : The PMDA evaluates the manufacturing process and quality control measures of the generic drug to ensure compliance with Japanese regulatory standards. Pharmaceutical Regulations in Japan 2020. Freyr Solutions. 11 Must-know FAQs about the Drug Approval Process in Japan.

Drug Development

Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

Clinical Development

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

Drug Target Review

APRIL 30, 2025

Building trust in AI – both among regulators and clinicians – will be key to unlocking its full potential in CGT, she explains. In manufacturing, AI-driven automation can optimise workflows, reduce errors, and ensure compliance with regulatory standards.

Drugs

Reprocell

AUGUST 1, 2025

But what is expected of a cell therapy developer to ensure compliance to meet regulators’ expectations across regions? The stem cell community is aware of the need for a harmonized and effective way to assess the genetic integrity of stem cell-based therapy programs.

Therapies

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. The goal of ICPs is to improve the quality of life for patients suffering from chronic respiratory diseases.

Production

ProRelix Research

MAY 13, 2025

The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades. 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.

Clinical Trials

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. Source link

Therapies

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

Alta Sciences

FEBRUARY 19, 2025

Beyond bioanalysis, understanding the mechanism of action is equally important, as different classes of oligonucleotidessuch as antisense oligonucleotides (ASOs)interact with mRNA in distinct ways to regulate gene expression. Our experts stay up to date on all new and evolving regulations to guarantee regulatory compliance in your studies.

Drug Development

PPD

JULY 8, 2025

Errors jeopardize patient safety, regulatory compliance and trust. In regulated domains, every step must be documented, auditable and reproducible to meet stringent regulatory requirements. No clear validation metrics: Performance is difficult to benchmark in regulated, high-stakes domains. But the stakes are uniquely high.

Clinical Research

thought leadership

DECEMBER 9, 2024

In the decades since the FDA first introduced Good Manufacturing Practice (GMP) regulations, the drug and device industry has undergone significant transformation. Additionally, as regulators worldwide adopt more rigorous data integrity and compliance requirements, scrutiny of quality systems has intensified.

Science

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. Supply chain disruptions Availability is a critical bottleneck in NHP-based research.

Drug Research

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

Perficient: Drug Development

FEBRUARY 12, 2025

The industry faces numerous challenges, including protecting sensitive data, navigating evolving regulations, and outdated legacy systems. This transformation will require a delicate balance between innovation and compliance, ensuring that advancements in AI contribute to a secure and efficient payments landscape.

Compliance

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.

Drug Development

The Premier Consulting Blog

DECEMBER 10, 2024

In addition to validation data for the analytical methods used to test the API and drug product to demonstrate accuracy, precision, specificity, and robustness, the sponsor should provide results from multiple batches to show consistency and compliance with specifications. Compliance with good manufacturing practices (GMP).

Marketing

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

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.

Government

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.

Compliance

Advarra

JULY 3, 2025

As such, research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance. 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.

Compliance

Alta Sciences

NOVEMBER 15, 2024

Once a confidentiality agreement is in place, the CRO should be able to share their site and study audit records, offering valuable insights into their adherence to regulatory guidelines and their ability to meet compliance standards.

Drug Development

thought leadership

APRIL 14, 2025

Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). While these countries are centrally located in Europe, they each have distinct national regulations that must be met.

Compliance

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.

Engineering

Drug Target Review

JUNE 18, 2025

Long timelines, strict regulation and scientific uncertainty are part of the job. He works closely with pharmaceutical teams in Europe and North America to help them move faster, think differently and adapt without compromising on quality or compliance. In early-stage drug discovery, pressure is nothing new.

Drugs

Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). Regulatory compliance : Biologics are subject to strict regulatory requirements, including those related to manufacturing, labeling, and marketing.

Drugs

Drug Patent Watch

JANUARY 14, 2025

Navigating Regulatory and Compliance Challenges Understanding Global Regulatory Landscapes Pharmaceutical negotiations often span multiple jurisdictions, each with its own regulatory framework. Ensuring Ethical Compliance in Negotiations Ethical considerations are paramount in pharmaceutical negotiations.

Pharmaceuticals

Advarra

NOVEMBER 14, 2024

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

Clinical Trials

Drug Patent Watch

JANUARY 9, 2025

Managing Quality and Compliance Quality and regulatory compliance are non-negotiable in pharmaceutical manufacturing. Navigating Regulatory Challenges Regulatory compliance is a complex area, especially for startups. Q: How can I ensure my CDMO is staying compliant with evolving regulations?

Compliance

PPD

JUNE 17, 2025

The right FSP partner implements this structure in a way that ensures efficient governance and an optimized oversight infrastructure, thus ensuring that sponsors maximize the benefits of this model while preserving quality and compliance.

Clinical Development

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

Perficient: Drug Development

FEBRUARY 26, 2025

From business goals and priorities, page views, conversion rate, SEO considerations and marketing campaigns, to compliance and regulations. Various different factors can impact this decision. Ultimately, it is important to assess the value each page has to the business and make decisions accordingly.

Marketing

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.

Regulations

Perficient: Drug Development

NOVEMBER 1, 2024

Protecting this data from breaches and ensuring compliance with regulations like HIPAA is essential to maintain patient trust and confidentiality. Continuous Evaluation : AI technologies should be subject to continuous evaluation and regulation to ensure they meet safety standards and adapt to new medical insights.

Treatment

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

“Regulators are also much more interested in the manufacturing process, especially when it comes to stability.” Solvias works closely with its clients to ensure that these challenges are met head-on, providing the necessary insights to streamline production and compliance processes.

Drug Development