Regulatory Affairs

 

Category:

Exhibitor: AMAREX TAIWAN, LLC

Booth No: N/A

 

Characteristic

 

Amarex's regulatory department has vast experience working with expert regulatory authorities around the world. Our expertise ensures that regulatory strategies are considered at every step to help gain product registration. We provide submission strategies that support early clinical development, product registration and late-phase trials. Our competitive advantage lies in the experience we have guiding our clients from strategy to FDA submissions. Our experience enables our clients to have the best representation when exhibiting the science, safety and efficacy of their medical product to regulatory agencies.
Services include:
1. FDA Applications and Submissions: IND, IDE, 510(k), NDA (eCTD), BLA, PMA, ANDA, Orphan Drug Designation and Break-through Therapy Designation
2. Regulatory Strategy
3. CMC Expertise
4. International Regulatory Agency Submissions (CTA, IMPD, MA, CE) and Meetings
5. GLP, GCP, GMP, GAP Audits and Certifications
6. Clinical Research Results Evaluation
7. Clinical Development Plan
8. Product Development Assessments
9. Regulatory Affairs IND Enabling Guidance (Pre-Clinical & Manufacturing)

 

Other Products

 

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  Consulting Services

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  Risk Based Monitoring

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  Clinical Site Feasibility

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  Clinical Operations

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  Medical Writing

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  Pharmacovigilance

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  Biostatistics

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  Data Management

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  Project Management

 

 

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