Strategic Product Development Consultancy

Improving health research and establishing a link with the Market

Teste SPDC MJQ

Maria João Queiroz, MD, Global CEO & Co-Founder

A product development plan may start out as a Gap Analysis or Due Diligence to better understand the road ahead for a certain drug or medical device. When outlining a drug development roadmap, there are key elements to consider, going from the designing of non-clinical and clinical studies, understanding the regulatory agency requirements, to knowing the market landscape.

As your partner CRO from the initial clinical research question, at Eurotrials we are committed to present you the best capabilities and expertise for your needs.

Eurotrials’s Product Development Team, comprised of scientists together with pre-clinical and clinical experts, has the necessary competencies and experience to provide support in the strategic product development process to clients in the Pharmaceutical Industry, Biotech and Medtech companies, Research Groups among others.

You start with a question, we will build the answer together.

 

In the current evolving landscape, clinical development is becoming an increasingly intricate and cross-functional process, adapting to an ever growing scientific understanding of the disease, to the availability of real world data in regulatory environment which is often challenging. Progress is made through the use of innovative approaches and techniques to develop more targeted therapies and personalized medicines.

R&D STRATEGY CLINICAL DEVELOPMENT REGULATORY SCIENCES PHARMACOVIGILANCE MARKET ACCESS REAL WORLD EVIDENCE ADAPTIVE TRIAL DESIGN REGULATORY REGULATORY RISK MANAGEMENT HEOR PHARMACO- PREVALENCE/ DISEASE TECHNOLOGY TRANSLATIONAL (PHASE I-IV) INTELLIGENCE STRATEGY PLANS (PASS, PAES) HTA ECONOMY INCIDENCE REGISTRY TRANSFER MEDICINE STUDIES PATIENT DATAPATIENTCENTRICITY

Regulatory Sciences

Concerns the regulatory and legal requirements of biomedical product development to the scientific research needed to ensure the safety and efficacy of such products.

Regulatory intelligence

Relates to processing targeted information and data from various sources, analysing the data in its relevant context and generating a meaningful output to the regulatory strategy. The process is driven by business needs and linked to decisions and actions.

Regulatory strategy

Is the plan outlined for the successful approval of the development candidate. It is heavily based on a through intelligence work (for example, knowledge of relevant guidance documents, regulatory framework) and is highly interactive with other disciplines (for example, a clinical development plan based on scientific advice from a Health Authority which was set out according with the regulatory rules).