REGULATORY AFFAIRS
Drug Regulatory Affairs (DRA) is a specialized field within the Hendrix pharmaceuticals that
focuses on ensuring the development, approval, and post-approval compliance of
pharmaceutical products with the regulations and guidelines set forth by regulatory
authorities in different countries. The primary goal of DRA is to ensure the safety, efficacy, and
quality of pharmaceutical products for the benefit of public health.
Key Responsibilities of Drug Regulatory Affairs Department:
Regulatory Strategy Development:
DRA professionals collaborate with cross-functional
teams to create strategic plans for the development and submission of new drugs or
modifications to existing products. They consider regional and international regulatory
requirements to ensure successful approval.
Medication inquiries:
DRA experts prepare and submit various types of regulatory
documents to health authorities, including investigational new drug applications (INDs), new
drug applications (NDAs), biologics license applications (BLAs), and marketing authoraization
applications (MAAs).
Safety Monitoring and Pharmacovigilance:
Our team monitor and report adverse events and safety data to regulatory agencies. They play a crucial role in ensuring the ongoing safety
of marketed products.
Lifecycle Management:
Hendrix experts manage post-approval activities, including
variations, renewals, and updates to product registrations. They may also work on strategies
for patent extensions and exclusivity periods.
Regulatory Intelligence:
Our DRA professionals stay updated on changes in regulations,
guidelines, and policies in different regions and advise their organizations on potential
impacts.
Clinical Trial Support:
Hendrix professionals collaborate with clinical development teams to
ensure that clinical trials are conducted in accordance with regulatory requirements.
Global Harmonization:
Our professionals strive to align regulatory processes across
different countries to promote consistency and facilitate global drug development.
