Regulatory Dossier Management
Regulatory lifecycle maintenance
TMF & electronic management
Compliance & Risk Management
What is Regulatory Affairs?
Alpha MD offers full service for NDA/IND/BLA/ANDA submissions under one roof for different countries. Our team has a combination of medical doctors and regulatory experts from reputed institutes who together understand the entire flow and reasoning of filing a new drug application.
Regulatory Affairs acts as a bridge between the pharmaceutical company and the government’s regulatory agency. It is a vital part of the organizational structure of pharmaceutical companies that have the primary responsibility of controlling safety and efficacy of pharma and medicinal products, by ensuring that they are marketed and licensed appropriately and comply with the regulatory specifications.