Life Science Consulting
December 6, 2022
Changes to the Animal Welfare Act Affecting Animal Research Facilities
Does your organization conduct or outsource testing to an Animal Research Facility? If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...
Life Science Consulting
November 1, 2022
Be Careful What You Ask For (Prior to Consent)
According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...
Life Science Consulting
October 28, 2022
ProPharma Group's Dr David Crome to Act as Compliance Monitor to the MHRA
From April 2022, the MHRA has been developing a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) on behalf of companies that have...
Life Science Consulting
October 26, 2022
Your Vendor Audit Program: On-site or Remote / Virtual?
It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...
Life Science Consulting
October 20, 2022
Clinical (IMP) Drug Supply…It’s Complicated
Things to consider and how to ease the process IMP Supply Management is a journey where GMP meets GCP and GDP. This journey includes finance, flow of products and documentation. How a company manages...
North America
FDA News
August 30, 2022
USP and FDA Propose Updates to Good Storage and Distribution Practices
Updates have been announced by FDA and for USP <1079>. In this blog we cover these changes. USP USP <1079> has a series of chapters on Good Storage and Distribution Practices. Chapter <1079> applies...
Medical Device
PDP
August 15, 2022
FDA Pathways to Medical Device Approval
FDA Pathways to Medical Device Approval: Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical...
PDP
PMA
August 9, 2022
From Idea to Market: The Five Stages of Product Development
From Idea to Market: The Five Stages of Product Development. The exact product development process for medical devices differs from region to region, with different regulatory expectations that need...
Meet the Expert
Renata Pankiewicz
August 8, 2022
Meet the Expert: Renata Pankiewicz
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...