Robust preclinical work is, the foundation of drug development, usefulness of clinical trials downstream and then for patient care all come down to how good the preclinical data is That is where bulletproof quality control (QC) protocols come in handy.  A Pillar Quality Control for Preclinical Research  QC comprises a

Preclinical trials are an essential step in the development of drugs, acting as a bridge between basic science and human clinical trials. The traditional preclinical models that has been extensively used are performed in vitro and on animals for prediction of safety and efficacy of candidate drugs.  However, these methods

The FDA released the June 2023 version of the Guidance on “Content of Premarket Submissions for Device Software Functions,” and it is a major revision, impacting significantly your Quality Management System (QMS). Proper execution of these changes requires a methodological process. Here we provide some of the overview about how

Explores the vital role these consulting firms provide life science companies with their need for navigating through FDA inspections.  The FDA Inspection Challenge  Inspections and audits carried out by the FDA form an important part of the regulatory environment for life science firms. The FDA assessments which evaluate compliance with

Learn key considerations for the development of gene therapy products targeting rare diseases.  We know the medical landscape is changing, and vast leaps in gene therapy could significantly improve modern medicine The emerging biologic treatments offer new hope for rare conditions where there are no treatment options. Nevertheless, the development

Medical devices are integral to modern healthcare, aiding in diagnosis, treatment, and management of various medical conditions. As these devices directly impact patient safety and well-being, it is crucial to establish rigorous regulatory frameworks to ensure their quality and efficacy. The Food and Drug Administration (FDA), a key regulatory authority

This guide is designed to assist you in your path through FDA, a major bottleneck in the life science regulatory pathway.  Introduction  Privacy and compliance are the two biggest concerns in the life science industry due to their pivotal role they play in Patient safety. The process is laden with

Where we take you through the critical steps in advance for and during an FDA data integrity audit.  Introduction  In the life sciences space, data integrity underpins everything, it is not an option. When regulatory bodies such as U.S. Food and Drug Administration (FDA) perform an inspection or audit, they

Discover the most important points to consider and useful tips for creating successful and safety-focused trials in the rapidly changing area of mRNA-based therapy.  Among the innovative modalities studied in the context of drug development, mRNA therapeutics have quickly emerged with potential applications for a myriad of diseases such as

This complex industry landscape demands a tactical strategy, with direction from the best available regulatory consulting companies essential for putting in place robust procedures that are designed to ensure quality and compliance more than anything else.  The Importance of Data Integrity for mRNA Vaccine Manufacturing  Data integrity is core to

Read this guide to find your way through the complicated selection process and choose QMS software that suits both your business and regulatory requirements.  Introduction  Maintaining quality and conforming with regulations is imperative in life science industry. Ultimately, using QMS software ensures that your company is compliant with policies and

The field of medical devices has been a shining light for implementing new technologies and innovations that can save lives in the world of modern healthcare. In this world of rapid change, regulatory organizations like the Food and Drug Administration (FDA) are essential for protecting patient health and making certain

In the dynamic landscape of clinical research, the importance of a robust clinical operations team cannot be overstated. This team is the backbone of clinical trials, ensuring that studies are conducted efficiently, ethically, and in compliance with regulatory standards. Building a strong clinical operations team involves strategic recruitment, continuous training,

Pharmaceutical manufacturing is a sector where the role of supplier management is critical. It directly affects every aspect of product quality, safety and regulatory compliance. To comply with the regulations, pharmaceutical companies must have a strongly defined supplier management process in place that helps to ensure all their suppliers meet

While the biotech industry is a hotbed of innovation, it also straddles its own challenges, particularly for fledgling startups regarding the maze of licensing. For start-ups, licensing agreements are a means by which they can capitalize on the latest technologies, obtain funding and penetrate market areas. Still, a whopping 80%

The silent revolution you are about to see; AI is changing the rules of regulatory compliance in life sciences.  Regulatory compliance is an inflexible pillar in the life science industry, aimed at ensuring the safety, efficacy and quality of products that saves  human lives. The regulatory landscape has become more

Here we walk through the specifics of Vaccine Stability Testing and Shelf-Life Determination, revealing essential strategies and regulatory insights for successful development of mRNA immunotherapies.  Vaccine Stability Testing; Why Does it Matter?  1. Preserving Potency  The quality and  efficacy of mRNA immunotherapies depends on the maintenance of its potency over

Technology transfer (Tech Transfer) is a pivotal stage in the pharmaceutical, biotech and medical device industries that ensures the knowledge gap, process handover, guideline differences are met between manufacturing facilities. This fosters innovation, scalability and helps in providing a consistent product which is safe, efficacious and compliant. This comprehensive guide

We discuss how quality audits play a critical role in maintaining industry standards and protecting patient safety.  In the fast-moving environment of the worldwide medical device market, quality audits play a vital role in ensuring compliance with tough rules. Quality audits represent a reliable connection between producers and regulators making

Explore the impact of an 85% surge in vaccine success, turning trials into effective lifesavers. Join us in understanding the future of vaccine research. The world of vaccine development has witnessed something of an unprecedented surge in success rates, with an 85% increase in transition from preclinical to clinical. These

Discover how optimization of logistics in clinical trials can help you cut your costs and avoid expensive mistakes. Find out some effective strategies today!  In the high-stakes world of clinical trials, timing is everything. Shockingly, approximately 70% of clinical trials face delays, which can lead to increased costs, extended timelines,

7 shocking facts related to clinical trials, providing critical insights into successful clinical development plans (CDP). Do not miss this valuable information!  It is not only critical to navigate the regulatory maze, but also crucial for patient safety and, finally, getting innovative therapies to market. Unfortunately, far too many pharmaceutical