Pharmaceuticals & Generics
Making way to innovative medicines
As many prescription drugs are losing patent protection, the generic alternatives are emerging as a force in the drug market.
Pharmaceutical companies planning to introduce their generic medicine in the market are not required to demonstrate the safety and efficacy of the active substance, as this information has been already obtained from the pharmaceutical product. The generic must demonstrate bioequivalence to the original drug: trials designed to compare the release, absorption, and elimination of the active substance of the two products; and the similarity between both within pharmacokinetic parameters.
As there are important variations in local regulatory requirements for the design and conduct of these studies, it is very important to choose the best local CRO as your partner of choice, since the knowledge of different region requirements are essential for the success of any clinical project.
From tailor-made single services to a full service offer
Having worked with top pharmaceutical companies from around the world, Eurotrials has the resources to support pharmaceutical companies’ projects across Europe and Latin America. We excel at operational quality and scientific expertise to deliver tailored solutions in pharmaceuticals and generics clinical research projects. Our team can help you manage complex pipelines and build a project that proves your product’s value from early to late phases, complying with regulatory, quality, safety and efficacy requirements.
Clients value Eurotrials’ more than 20-year history of clinical research projects. We are committed to consistently deliver added value by advancing collective goals, building strong client partnerships and focusing on the establishment of performance achievements that help each client reach key goals on time and on budget.
Our full range of drug development services, which meet international and local regulatory standards, is aimed at providing a complete package of pharmaceutical services considering our clients’ needs at the moment.