Take the first step towards drug marketing – Pharmaceutical Dossiers
Lead the legal run!
As a critical element of the product registration process, pharmaceutical dossiers are essential documents to be submitted at the Food and Drug Administration of the Health Ministry. Gaining approval to market drugs calls for submission of these documents to the regulatory agencies. The Dossier comprises of documents which state the years in research as well as multi-disciplinary information regarding he efficiency and safety of the drug, including pre-clinical and clinical data.
Dossier Management Made Easy for You
Variations are observed among countries, as far as the process of Dossier Submission is concerned. These also involve countless communications between the regulatory authority and the sponsor or the submitting company. It is the sponsor’s responsibility to compile all data in its true form and present in the prescribed format. Now that is indeed something complex, involving management of all elements and considerable costs for approval.
Why don’t you leave it to the experts! We have a team to help you in writing as well a registration of Pharmaceutical Dossiers. We have been involved in it from scratch, including validation of data, providing expert reports compilation of the dossier as well as application for registrations in the pharma industry.
The exhaustive, highly detailed document on drugs entails extensive data on all the aspects involved, calling for sourcing skills, interpreting the same and presenting in the legal document. It needs a team of skilled data analysts, talented pharmacists and research assistants. Contact us for the best experience involving minimal time and cost.
The Tales of Successful Research and Development – Clinical Trials
A potential new medicine has a life full of ups and downs, but a pivotal moment in the same is the clinical trials, or the test on human volunteers. The impact of a new devised treatment, with a potential to be used in future can only be determined by clinical trials. These trials provide the Food and Drug Administration with all the scientific details which are required to analyse the risks and benefits of the new drug and decide whether it is safe for distribution and use, or not.
Clinical trials can be aptly termed as the biomedical or the health related research studies, following a pre-defined protocol, and performed on human volunteers. These are conducted to study certain diseases, to investigate new methods to use known disease treatments or to analyse the new potential treatments and medications.
For experimental drugs, the testing is usually conducted in three phases, which have varied purposes. The number of subjects increases in each phase to test potential benefits and safety of the drug or treatment.
Why and who can participate in clinical trials?
Participants become major contributors to medical research and also gain access to new treatments before their commercial launch.
All clinical trials have a set of guidelines to state about the requirement in terms of the participants. It includes the specifications such as gender, age, type of disease, etc. These actors eventually lead to identification of the participants.