Regulatory Documents

The practice of evidence based medicine, the corresponding increase in clinical trials and with new drugs and medical devices now entering the market, warrants the need for stringent regulatory norms and standards. This is mainly attributed to adverse events that have occurred from medical drugs and devices. Needless to say, pharmaceutical manufacturers as wells medical device and equipment manufacturers are now expected to adhere fully to prescribed norms and regulations prior to launching a new drug, medical device or equipment.

The key focus is on enhancing safety and reducing the scope of risk from any medicinal products or medical device or equipment. The European Union on April 5th, 2017 adopted two new regulations for medical devices and in vitro medical devices. These were actively enforced on May 25th, 2017 and intended to progressively substitute the existing directives. The transition from the old to new directives were expected to occur in May 2020 for medical devices while for in vitro devices, the date set forth was May 2022. With this shift, medical device manufacturers are expected to adhere to strict regulations and comply with the norms as prescribed. This warrants the need for more regulatory documents.

At Phraseaway, our team of specialized and experienced regulatory writers are abreast of the latest developments in the regulatory environment and capable of delivering precise, cost-effective regulatory and clinical documents on time. We don’t compromise on quality and maintain the highest level in scientific standards. Our robust team of regulatory writers are well-versed with the finer nuances of regulatory writing and are adept at creating regulatory documents. With their knowledge and experience, they are in a position to also offer appropriate guidance in

1. Preparing patient information leaflets
2. Prescribing/product information
3. Web synopsis
4. Standard response letters.

Let us know what you need!