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GPC has access to excellent regulatory input from experts experienced in getting pharmaceuticals and devices through the approval process in Europe, Japan and USA.
GPC regulatory personnel have detailed knowledge of global regulatory approval systems and pricing and re-imbursement requirements.
GPC can assist in the preparation of the appropriate internal reports prior to regulatory submissions; including investigator's brochures, SOPS, clinical reports, expert reports and product monographs.
GPC will also organise submission of IND applications / NDAs and enter into discussion with regulatory bodies on behalf of clients.
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