Regulatory Affair Consulting
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
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