White Papers

Use of Retrospective RWD for MDR Compliance

As EU MDR has already entered into force and will be applicable in May 2020,the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence.

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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.

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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.

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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.

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First Time Right Filing June 2016

Many large and medium biopharma companies operate in 100+ countries. It’s highly challenging to meet regulatory requirements for product approval of new and generic drug fillings, assuring regulatory compliance, and maintaining lifecycle of regulatory authorizations and established guidelines in these countries.

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