eCTD submission

Bosnia and Hercegovina implemented NeeS and will be mandatory as of 1 July 2015 for all submissions

The Agency for Medicines and Medical Devices BiH announced acceptance of documents for methods of administering / changes / renewal of the authorization in NeeS format. ALMBIH will accept NeeS submissions for any type of submissions relating to regulatory affairs, including: granting licenses, renewal, variation, transfer or revocation / withdrawal of the license, PSUR and […]

eCTD submission

Common Electronic Submission Gateway (CESG) for Regulatory Transaction at Health Canada for Health Product

In January 2013, CESG is part of ESG for regulatory submission of medicinal product to Canada means Health Canada is participating with the USFDA, to reduce regulatory burden for health products as part of the Canada-U.S. If you are already registered with the FDA as a Trading Partner and now wish to do business with […]

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