Marketing Authorisation Applications for human medicines & medical devices
CTD conversion of historical documents
Abstracts, Overviews and Summaries
Review Clinical Study Reports
Review SmPC, PIL and PSUR
Healthcare reports and medical documents beyond that for Regulatory submissions
Regulatory Medical Writing
Within the last fifteen years or so, I have prepared complete set of clinical modules for the regulatory submissions of at least 48 different products for more than 27 large to medium-sized pharmaceutical companies in the EU and USA. The submissions, either generic or bibliographic, have included both new active substances as well as abridged applications, including variations and extensions to the existing licenses, through national, centralised, decentralised and mutual recognition procedures. In addition to the CTD modules, I have prepared expert reports on further new, pipeline or existing products. I have also prepared Clinical Evaluation Reports (CER) for the marketing authorisation applications for medical devices.
I have the experience of preparing medical reports and documents for a variety of purposes beyond that for regulatory use. Clinical experience and medical knowledge that I have accumulated over the years enables me to research for precise and purpose-oriented medical information over a wide range of medical specialties. The documents I have prepared have been instrumental in the education, training and professional development of doctors and other health professionals; establishing and restructuring health services; and, providing guidelines for the implementation of those services.
As a medical doctor, I possess the knowledge and skills of providing acute, chronic and emergency treatment to cure patients. As a family health physician, I have trained doctors and paramedics in family planning, and have conducted more than a thousand surgical sterilisations myself, in addition to an array of other medical services that I have delivered through specialised clinics and mobile camps at remote areas of Nepal that are accessible only through strenuous trekking.