Bioavailability / Bioequivalence Centers
The International CROs that intend to be certificated by Anvisa, must contact a national company to represent them at Anvisa. The selected national company will be responsible for the submission of specific application forms for first certification or certification renewal.
It is recommended that the application form for certification renewal be submitted at least 180 days before the expire date.
All necessary guidelines, documents and application forms are available below.
Application Forms
Certification for Medicine Bioavailability/Bioequivalence Centers (word)
Regulation: