Hello,
I am looking for guidance on the regulatory requirements for the
labeling and import shipment of my company's Drug Substance API (used
for clinical trials and not approved for commercial) into Israel. Can
someone direct me to the applicable requirements? We are looking to
supply a compassionate-type use need with our API and we're not clear
on the
regulatory requirements which we need to comply with for labeling /
packaging, notification of regulatory bodies (FDA/Israel), import
documentation, or others. Thank you in advance for your help.
Sincerely,
Gerry Hara
(gerryhara@gmail.com)
ADC Tech Services
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Gerry Hara
gerryhara@gmail.com
ADC Consulting
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