PharmaLex offers tailor made solutions:
we can either manage your whole registration
process or only parts of it. It’s your choice.
Our gift of time
A lot of time can be lost when registering a drug because of a lack of optimal coordination among different departments. For instance the pharmaceutical development or the delivery of the clinical trials reports may not be according to schedule. Our advice: put your drug registration in our hands.
PharmaLex will gladly take over the coordination during and after the registration process. We know how to manage the interdisciplinary tasks so that the different departments of your company can work efficiently together. We are supported by a network of experts in pharmaceutical, pharmacological, toxicological, clinical (CRO) areas, production and sales.
Registration consultants “on demand” – our solution to your backlog
Registration departments all suffer the same problems. In the rapid cycle of action and reaction during a registration process the short-term peaks in the demand for staff cannot be covered. Simply put, registration departments are always living on the edge and this can have major consequences for successful registration.
PharmaLex International has the solution to your problems. Our highly qualified registration experts can assist you in all fields. Our consultants will evaluate your documents in view of current rules and guidelines, compile a complete electronic dossier (optional electronically), and supervise the entire process.
Alternatively we can offer you the “PEP” solution: PharmaLex Expert Partner. These are interim managers that can strengthen your team in-house and help to accelerate the registration process. We can even provide you with a PEP on a long-term basis. If you require a “Qualified Person” a “Drug Safety Officer” or “Information Officer”, we can help.
The professional touch for the final finish
As your partner we are always proud when a PharmaLex registration dossier is given the green light from the authorities. This means that we made a decisive contribution to securing the success of our client’s high investment in product development. We succeed because we leave nothing to chance. Our registration checklists are not only an aid for us, but bring structure to departments on the long route through the authorities. In the end it is your innovation that finds its way rapidly and quickly onto the market.
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