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Thank you for your comment. I appreciate your concerns and as a member of the RAC Board (for whom I volunteer) I would like to address them as best I can. In the past, we received many requests from potential applicants to provide exams that were sector based. In 2017 a more formal process to review ...

Hello Julie, Just to add a bit more of information to your post. In the case of ANVISA/Brazil inspections (and subsequent GMP Certification), are paid for the companies (local established companies). It is a very interesting question. Who do you, Julie, think should pay for regulatory inspections? ...

Dear Arden, To apply for an INN you need to submit your request directly to WHO. You must use WHO specific form which can be filled in electronically if your country does not have a National Nomenclature Commission. Please feel fre to contact me @ saadma@marcmconsulting.ca if you need further details. ...

Good morning! In Chile there is a project of Law under implementation, at this point registration is not yet required. However, the voluntary registration is highly recommended. To do so, your company must have a local legal representation, which means a local partner (i.e. distributor established ...

Hello, INVIMA, the health agency in Colombia, authorizes an import procedure called "Uso Compasivo". Through this type of import the patient is able to access drugs approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient's home country. ...