Regulatory Services
Entry into the enormous world of pharmaceutical products in international markets necessitates a thorough awareness of the complex regulatory requirements. Tooba Healthcare LLP's Drug Regulatory Affairs (DRA) consultants help companies design and manage pharmaceutical and medical product development projects, as well as regulatory obligations. We make it easier to get your products approved quickly by creating country-specific regulatory strategies early in the product development process and removing potential bottlenecks on the way to a successful product launch.
Our Regulatory Services include
Registration services.
- Preparing, reviewing, and submitting DMFs (CTD format).
- Writing and reviewing dossiers
- Registering Dossier
- Obtaining COAs and COPPs
- Notarizing documents
Changes made after approval
- Re-registering products.
- Scheduling site renewals
- Maintaining post-approval lifecycles
- Publishing reports
Pre-registration Services:
