REGULATORY AFFAIRS

We at Virchow Laboratories have built our regulatory team from the ground up comprised of efficient, hardworking, competent professionals with an extensive experience of the pharma regulatory requirements amongst them.

Our regulatory team is equipped to work in synergy with both the marketing and manufacturing teams. This includes processes beginning right from the nascent stages of product selection, compiling the required CTDs, ACTDs, eCTDs, through the life-cycle of product launch, and even during the post-launch activities.

Through their tireless efforts we have obtained approvals of INVIMA (Colombia), PIC/S (Ukraine), Ghana, Uganda, Kenya, Philippines to name a few, as well as having US FDA 510(k) approvals for various products.

Our clinical development team is also equipped to prepare clinical trial protocols and tie up with leading hospitals and clinical trial centers to successfully execute and manage various forms of clinical trials and studies.

Today’s regulatory landscape is ever changing and staying up-to-date is always a challenge for any company. Our regulatory team’s ability to always stay abreast of the current and even upcoming trends gives Virchow an edge.