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Orient Pharma offers a wide range of service to help sponsors whether in Taiwan or overseas (US, ASEAN, Japan etc.) to precede product registration or other needs.
General Activities | |
Evaluation of the adherence to regulations and applicable guidelines for regulatory dossiers | |
Advice on registration strategy and health authority requirements | |
Interpretation of guidance documents | |
Liaison with the regulatory authorities | |
Facilitation of local concerns via a network of partners in US, Japan, and ASEAN countries | |
Pharmaceutical Product | |
Preparation and submission of registration dossiers for Marketing Authorization and variation application | |
Management of regulatory procedures | |
Drug Master File (DMF) preparation and submission to Taiwan FDA | |
Plant Master File (PMF) preparation and submission to Taiwan FDA |