Business Activities
Regulatory Affairs

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

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