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Regulatory Affair Consulting

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Pharma is nowadays one of the most regulated industries. Compliance with regulations and regulatory institutions is a non-negotiable in clinical development.

We offer support for Investigational New Drug (IND) applications, New Drug Authorization (NDA) submissions, renewal applications as well as compliance to post-approval activities.

Clinical Trial Regulatory Services

Clinical trials produce vast amounts of sensitive and high-quality data, which requires an efficient data management solution that covers all aspects. To ensure that the research’s conclusions are well-supported, the clinical data management system must guarantee that the collection, availability, and integration of data meet appropriate quality standards and are within the stipulated cost.

Clinvigilant  EDC  seamlessly transforms data recorded on paper into an electronic case report form (eCRF), that can be used  for both simple and complex trials in all phases of the research.

Market Access and HEOR (Health Economics and Outcomes Research) Consulting

Pharmacoeconomic studies need data mining from different sources as well as market research surveys. Government healthcare policies, reimbursements and health insurance including treatment guidelines and algorithms are important determinants to understand healthcare economics and outcome research. Our wide network of hospitals, clinicians, government agencies, and medical societies can help conduct such programs providing support to develop pharmacoeconomic models to decrease treatment costs .

We are always available for a conversation.

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