Generic Drug User Fee Amendments
The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug…
DDReg is India based regulatory consulting and services provider organization. DDReg supports large, medium, and small size pharmaceutical companies in their entire regulatory value chain ranging from new product authorizations, regulatory strategy, submissions to post-approval/life cycle management, labeling, and other related functions.
As one of the leading pharmaceutical consulting firms, DDReg is involved in a wide variety of pharma regulatory assignments from organizations across the globe for regulated and emerging markets. We are led by experts with a combined experience of ~80 years in handling global regulatory assignments & medical writing projects.
A multi-disciplinary team of qualified regulatory affairs personnel ensure exceptional-quality services and reduced time-to-market.
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Impact of Brexit on the Pharmaceutical Industry
The pharmaceutical industry is one of the most important industries that will be directly impacted by Brexit. When the United Kingdom’s referendum was held in…
Nitrosamine Impurities: A Regulatory Perspective
In July 2018, the European medicines regulatory network became aware of the presence of nitrosamine impurities in an Active Pharmaceutical Ingredient (API). This was the…
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