By assigning us some of the documentation work, you could focus on the product development activities. From the data and documents generated by you, we can assist in preparing the executive summary, product introduction, evidence of effectiveness, and benefit-risk assessment.
We can review, update, or even write completely some of the sections of your dossiers. With our medical, safety, and pharmacological expertise, we can update or write the following section:
Analysis of target disease condition, analysis of current treatment options, and worldwide regulatory and marketing history.
From the information generated by you, we can develop clinical conclusions on efficacy and safety. Incorporate important sections to the product dossier, including a description of product quality, clinical microbiology, nonclinical pharmacology/toxicology, and clinical pharmacology (mechanism of action, pharmacodynamics, and pharmacokinetics).
If there are medical devices or medical diagnostic issues, we can address them. We can assist with the need for clinical evidence and define the assessment of benefit risks. We can review and incorporate information from any consumer study conducted and use global published information to support the product.
