Biotech Regulatory Support
Welcome to The Pall Biotech Regulatory Pages
Transparency and partnership are at the heart of Pall Biotech and we know the availability of high quality product documentation helps you manage the vast amount of documentation required for regulatory submission; This portal collates all current documentation to help you navigate compliance quickly and efficiently, and the electronic regulatory dossiers help you in your ongoing risk assessments and will take the stress out of preparing documentation for regulatory compliance and audits.
This portal gives you direct access to the documents you need. Just register, and then download all the required information.
Regulatory Documentation: Review and download general compliance statements and product specific regulatory documents
Quality Documentation: Access and download Pall’s essential quality documents, ISO certifications, supplier information, and safety data.
SME Corner: Access prior knowledge from our subject matter experts (SMEs) as well as perspectives relating to regulatory and compliance-focused ‘hot’ topics. The current categories include:
o Approach to sterility o Pre-use post sterilization integrity test o Industry interest groups
o Extractables and leachables o Particles management o Integrity testing
o Integrity of single-use systems o Change management o Sterile filter validation
To learn more from our Subject Matter Experts take a look at the available articles here.
Resources: Links to webinars and other informative web pages, including external links to industry groups, white papers and relevant standards
Using this portal, you can also request a product batch certificate or file your complaints and track the advancement of the investigations.