Regulatory affairs (RA) is a profession in the life science industry that involves checking whether a business is following official rules or laws regarding the safety and efficacy of products. Regulatory affairs professionals supervise the developing, testing,...
News & Blog
Handling Deviations in a Life Science Environment
Deviations from standard procedures can greatly impact quality and compliance in life science facilities and the pharmaceutical industry. This blog explores best practices for identifying, investigating, and documenting deviations. It covers determining common causes,...
A Simple and Helpful Guide to Quality Document Review
Quality assurance (QA) is a process that helps a business ensure its products or services meet the quality standards set by the company or its regulatory requirements. QA is involved in all stages of a product’s development, from raw material delivery through...
PSC Biotech and PSC Software: The One-Stop Solution for All Your Life Science Needs
The BIO International Convention is the premier event for the global biotechnology industry, where you can network with thousands of peers, leaders, and partners and discover the latest innovations and opportunities in the life science sector. This year, the...
Precision: Driving Success in Life Science through Calibration & Metrology
Metrology is critical to any life science manufacturing process in a highly technical and regulated industry. At PSC Biotech, we offer a range of metrology services to help our clients maintain equipment and systems compliance requirements and ensure their...
Regulatory Strategy Development for Life Sciences: Best Practices
Regulatory Affairs and Winning Regulatory Strategy Regulatory strategy development is critical for life sciences companies seeking to bring new drugs, medical devices, and other products to market. Developing an effective regulatory strategy can help companies...
The Secret to Writing Successful Grant Proposals
Grant writing aims to prepare and submit a proposal to request funding from a grant-making organization, such as a government agency, private foundation, or corporation. Grant writing involves researching potential funders, understanding their priorities and...
Benefit- Risk Assessment for Regulatory process
Benefit-risk assessment is critical to the regulatory review process for life science companies and healthcare products, including drugs, biologics, and medical devices, before it is approved for use by regulatory agencies such as the Food and Drug Administration...
Navigating Regulatory Inspections: Top 5 Remediation Best Practices
Regulatory compliance is essential in all industries, but it is easier said than done. Regulatory agencies strictly monitor organizations to ensure they adhere to the applicable rules and regulations. In doing so, they conduct regular inspections, and companies can...
Annual Submissions for US in regulatory processes
Annual submissions are critical in regulatorysubmission processes to maintain a product’s quality, safety, and efficacy over its duration in the market. These submissions are part of post-marketing activities for the product and are an essential part of the product’s...