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Regulatory Submission
Product registration
- Drug product, medical device, cosmetics, OTC, etc.
- QSD, DMF, PMF submission
- Post-approval changes
CTA submission
- Drug product, medical device cosmetics, etc.
- IRB/EC & TFDA submission
- Study amendment
- Annual renewal
Contract/budget submission
- Clinical trial agreement/budget submission
- Ancillary agreement
- Agreement amendment