Regulatory Medical Writing

Within the last four years, I have prepared complete set of clinical modules for regulatory submissions of at least 30 different products for more than 20 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 and mutual recognition procedures.

In addition to the CTD modules, I have prepared expert reports on further products for renewal of their licenses, and have offered expert advice on the preparation and updating of new and existing documents for regulatory and other needs in the future.  

Medical Writing

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 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.

Clinical experience

As a medical doctor, I possess the skills of providing acute, chronic and emergency treatment and cure to 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 services that I have delivered through specialised clinics and mobile camps at remote areas accessible only through strenuous trekking.