Clinical Research Solutions
Top 10 Best Practices for Successfully Obtaining Second Round of Funding for Biotech Startups
Securing funding is a crucial milestone for biotech startups aiming to advance their research and bring innovative products to market. Once the initial round of funding is secured, the next challenge...
Clinical Research Solutions
Biotech Start Up: How to Transition from Early Phase Biotech to Late-Stage Biotech
Biotech startups face a number of challenges as they progress through the various stages of drug development. While early-stage biotechs focus on developing and testing their products, late-stage...
Clinical Research Solutions
Compliance Auditing: A Peek into Common Critical Findings
Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices. Compliance...
Clinical Research Solutions
What You Need to Know About GxP Independent Compliance Audits, Part 2
Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1, we discussed the importance of GxP audits, the different audit types, and why...
Clinical Research Solutions
What You Need to Know About GxP Independent Compliance Audits, Part 1
In this post, we’re going to discuss the various types of GxP Compliance Audits, internal versus independent third-party audits. the role that independent auditors play in conducting compliance...
Clinical Research Solutions
Revised Annex 1, EudraLex Volume 4: Deadline to Comply: August 2023
The deadline to comply with the revised EudraLex Volume 4, Annex 1 is August 25th, 2013. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...
Clinical Research Solutions
7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing
Developing, optimising, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CAGT) products is extremely complex. The choice of a reliable Contract...
Clinical Research Solutions
How to Select the “Right” CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company’s needs. Every company knows, timing is critical to success. But...
Clinical Research Solutions
Prepare for Your Next Audit: A 5-Point GMP Checklist
Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so...
Quality & Compliance
6 Tips to Prepare Your Medical Cannabis Facility for Inspection
You may be considering building a new facility for growing, harvesting, and processing medical cannabis, or perhaps you have an existing facility and want to export to the European Union. What should...