Inspection and registration related services
Service Scope
Consultation covers various product categories, such as drugs, medical devices, cosmetics, food/dietary supplements, new biotechnology products, environmental agents, combination products, etc. We can provide consultation services including general regulatory interpretation, case strategy assessment, case submission counseling, etc. at different critical stages of the product lifecycle from discovery and development to post-marketing management.
Product life cycle
Clinical trials
- Phase I/II/III/IV
- Generic drugs bioequivalence Study/Usabilities
- Exemption from the requirement for pre-clinical
- Regulatory compliance
Registration
- Registration application
- Bridging study evaluation
- New product review process
- Patent Dance
- Regulatory compliance
Post-marketing management
- Pharmacovigilance
- Risk management
- Reporting severe adverse reactions
- Drug injury relief
- Advertisement
- Pricing
Medicinal Products
- New Chemical Entity (NCE)
- New Administration Route
- New Indication
- New Combination
- New Dosage Form
- New Dose
- New Strength
- Orphan Drug
- Bridging Study Evaluation (BSE)
- Generic Drug (Generic Product)
- Over The Counter Drug (OTC Drug)
- Controlled Drug
- Bioavailability (BA)
- Bioequivalence (BE)
- Dissolution
- Re-registration/Change/Variation
- Transference
- License Renewal
- PIC/S GMP
- Plant Master File (PMF)
- Good distribution Practice (GDP)
- Inspection
- Transference and Authorization
- Renewal
- Registration of Drug Substance
- Application of Drug Master File (DMF)
- Transference and Authorization
- Re-registration/Change/Variation
- Raw Material Limited to The Drug
- Manufacturer Self Use
- Special Import
- Advertisement
- Consultation
Medical Devices
- Class I Medical Device
- Class II Medical Device
- Class III Medical Device
- Class I Medical Device
- Class II Medical Device
- Class III Medical Device
- Re-registration/Change/Variation
- License Renewal
- Transference
- Class I Medical Device
- Class II Medical Device
- Class III Medical Device
- Re-registration/Change/Variation
- License Renewal
- Transference
- Quality System Documentation (QSD)
- Taiwan GMP
- Taiwan GDP
- Re-registration/Change/Variation
- License Renewal
- Authorization
- Advertisement
- Consultation
Cosmetics
- Registration of New Medicated Cosmetics
- Registration of General Medicated Cosmetics
- Re-registration
- Change/Variation
- Transference
- License Renewal
- Test/Assay for Registration of Medicated Cosmetics
- Advertisement
- Formula Reviewing
- Package Reviewing
- Consultation
Food/Supplements
- Health Food
- Imported Food in Tablet or Capsule Form (Dietary Supplement)
- Food Additive
- Genetically Modified Food
- Special Dietary Food
- Vitamin Supplement
- Ready-to-Eat Soy Bean Food
- Re-registration/Change/Variation
- Transference
- License Renewal
- Formula Reviewing
- Package Reviewing
- Consultation
Veterinary Drugs
- Registration of Veterinary Drugs
- Re-registration
- Change/Variation
- Transference
- License Renewal
- Consultation
Environmental Agent
- Registration of Environmental Agent
- Consultation
License Holder/Agent
- License Holder/Agent
- License Management
Contact us now
Are you interested in our services? Please click the button on the right or call +886-958251667