UDI in new EU MDR

Unique Device Identification (UDI) is intended to assign a unique identifier to medical devices within the United States it marks and identifies individual medical devices throughout their distribution and product life.

Changing Regulatory Landscape of preceding and forthcoming Years

In this whitepaper, we have compiled and simplified some of these new policies, revisions, regulatory amendments from registration,labeling, safety reporting, renewal, publishing /eCTD submission of last year and forthcoming years.

RA Strategy for Biopharma Acquisitions

The product registration requirements for various countries across the world vary from one another. No medicinal product can be placed in the market unless a marketing authorization is been granted by the competent authorities of each country.

Have Questions? Need Info/Quotes?