We ensure that our team possesses the knowledge of recent technology and the highest administrative abilities, as well as excellent knowledge of EU/US legislation to keep to the deadlines and restrictions imposed by local and international regulations. An extensive regulatory affairs strategy, with an individualized product portfolio.
- Comprehensive advice on how to address common regulatory hurdles and the impact of emerging and existing legislation
- Assurance that the correct regulatory conditions are in place and the appropriate submission route for your product (national, Decentralized, Mutual Recognition or Centralized) utilizing EXTEDO software for eCTD compilation and publishing
- Complex ANDA preparation including CMC, submission to FDA and management of ANDA Amendments
- Labeling compilation including legal approval
- Experience translations specialists with broad technical knowledge