REGULATORY MEDICAL WRITING

The medical and pharmaceutical domain is directly related to the life of the patients. The regulatory authorities have the responsibility for approving only those drugs and devices that proves good benefit-risk profiles based on the guidelines. Any issue in the data presentation in file for submission may result in the generation of query resulting in delayed approval and loss of revenues. The data for unsuccessful submissions are staggering and only half of the total applications submitted were approved on their initial submission. Further, the median period of delay in applications under the delayed approval category was approximately 435 days. Only an expert in regulatory filing helps in reducing the risk of unsuccessful submission.

Smiqgen is an expert in delivering high-quality authoring, reviewing and consultations services to clients who are planning or are about to submit their applications to the drug regulatory authorities. The regulatory medical writers and reviewers at Smiqgen have several years of experience in ensuring data accuracy and consistency. Further, Smiqgen also helps in formatting the document as per the guidelines and the eCTD template.