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Dr. Grace Tan

Dr. Grace Tan PharmD, RAC

Senior Regulatory Intelligence Lead

20 articles 🌏 Asia-Pacific

Dr. Grace Tan provides senior analysis on regulatory convergence, inspection priorities, and quality compliance for APAC manufacturers. Her 19 years in regulatory operations make her a trusted voice on launch risk and remediation planning.

regulatory strategyquality complianceinspection readiness

Articles by Dr. Grace Tan

SPONTAN Phase II Data Shows 10-Minute Onset Time, Meets FDA Requirements for Erectile Dysfunction Treatment
NewsMay 4, 2026

SPONTAN Phase II Data Shows 10-Minute Onset Time, Meets FDA Requirements for Erectile Dysfunction Treatment

SPONTAN Phase II interim results demonstrate 10-minute median onset versus 60 minutes for oral vardenafil, meeting FDA pharmacokinetic requirements.

Dr. Grace Tan
Purdue Pharma Dissolution Approved: What It Means for Opioid Crisis
NewsPainMay 3, 2026

Purdue Pharma Dissolution Approved: What It Means for Opioid Crisis

Purdue Pharma, the maker of OxyContin, is set to dissolve after a judge approved its criminal sentence. This landmark decision is a significant development in the ongoing legal battles surrounding the opioid crisis.

Dr. Grace Tan
FDA Approves First Non-Antipsychotic for Dementia Agitation
Newsagitation associated with dementia due to Alzheimer's diseaseMay 3, 2026

FDA Approves First Non-Antipsychotic for Dementia Agitation

The FDA has approved the first non-antipsychotic medication for agitation linked to dementia from Alzheimer's disease. This landmark approval provides a much-needed alternative to antipsychotics, which carry significant risks for this patient population.

Dr. Grace Tan
Local Pharmaceutical Manufacturing South Africa: SAHPRA Policy Impact 2025
AnalysisMay 2, 2026

Local Pharmaceutical Manufacturing South Africa: SAHPRA Policy Impact 2025

This article examines the implications of SAHPRA's 2025 policies on local pharmaceutical manufacturing in South Africa, focusing on drug accessibility and innovation.

Dr. Grace Tan
HIV Treatment Clinical Trials Africa: Long-Acting Injectables & AMA Pathways
AnalysisHIV/AIDSMay 2, 2026

HIV Treatment Clinical Trials Africa: Long-Acting Injectables & AMA Pathways

This article delves into HIV treatment clinical trials in Africa, highlighting long-acting injectables and the AMA pathways for enhanced patient care.

Dr. Grace Tan
Keenova Therapeutics Presents New TERLIVAZ Clinical Data for Hepatorenal Syndrome at Digestive Disease Week 2026
NewsMay 2, 2026

Keenova Therapeutics Presents New TERLIVAZ Clinical Data for Hepatorenal Syndrome at Digestive Disease Week 2026

Keenova Therapeutics shares new TERLIVAZ (terlipressin) clinical analysis for hepatorenal syndrome-acute kidney injury at DDW 2026, expanding treatment evidence.

Dr. Grace Tan
Verified Clinical Trials Partners with Chubb to Enhance Patient Safety and Data Quality in Clinical Research
NewsMay 1, 2026

Verified Clinical Trials Partners with Chubb to Enhance Patient Safety and Data Quality in Clinical Research

Verified Clinical Trials and Chubb announce strategic alliance to improve clinical trial participant safety, data quality, and study integrity worldwide.

Dr. Grace Tan
Genprex Receives Israel Patent for Reqorsa Gene Therapy Combined with PD-1 Antibodies in Cancer Treatment
NewsMay 1, 2026

Genprex Receives Israel Patent for Reqorsa Gene Therapy Combined with PD-1 Antibodies in Cancer Treatment

Genprex secures Israeli patent protection for Reqorsa gene therapy combination with PD-1 antibodies, strengthening intellectual property portfolio for cancer treatment.

Dr. Grace Tan
Bispecific Antibodies in Hematological Malignancies: Teclistamab, Mosunetuzumab & Epcoritamab FDA Review
Analysishematological malignanciesMay 1, 2026

Bispecific Antibodies in Hematological Malignancies: Teclistamab, Mosunetuzumab & Epcoritamab FDA Review

This article delves into the FDA review of bispecific antibodies teclistamab, mosunetuzumab, and epcoritamab for hematological malignancies.

Dr. Grace Tan
TLX597-Tx PSMA Radioligand Therapy Shows Promise in OPTIMAL-PSMA Trial for Early-Stage Prostate Cancer
NewsApr 30, 2026

TLX597-Tx PSMA Radioligand Therapy Shows Promise in OPTIMAL-PSMA Trial for Early-Stage Prostate Cancer

TLX597-Tx radioligand therapy demonstrates low organ toxicity in OPTIMAL-PSMA trial, potentially enabling dose intensification for prostate cancer treatment.

Dr. Grace Tan
EirGenix Expands Japan Biosimilar Strategy at CPHI Japan 2026 Amid Regulatory Support
NewsApr 29, 2026

EirGenix Expands Japan Biosimilar Strategy at CPHI Japan 2026 Amid Regulatory Support

EirGenix leverages Japan's supportive biosimilar regulatory framework and supply chain transformation to strengthen its strategic presence in the Japanese market.

Dr. Grace Tan
Digital Health Solutions in MEA Oncology: Impact on Treatment Monitoring & Outcomes
AnalysisoncologyApr 29, 2026

Digital Health Solutions in MEA Oncology: Impact on Treatment Monitoring & Outcomes

Digital health solutions are revolutionizing oncology in the MEA region, improving treatment monitoring and patient outcomes, particularly with therapies like Keytruda.

Dr. Grace Tan
Biosimilar Oncology Antibodies: EMA Market Dynamics & Healthcare Impact
AnalysisoncologyApr 29, 2026

Biosimilar Oncology Antibodies: EMA Market Dynamics & Healthcare Impact

This article delves into the market dynamics of biosimilar oncology antibodies, focusing on their role in cancer treatment and implications for healthcare systems.

Dr. Grace Tan
FDA Approval of Elarekibart: Current Status and Market Implications
AnalysisTreatment-Resistant HypertensionApr 29, 2026

FDA Approval of Elarekibart: Current Status and Market Implications

Elarekibart has received FDA approval for advanced melanoma, signaling a significant advancement in treatment options and potential shifts in the pharmaceutical market.

Dr. Grace Tan
SFDA Expedited Review Oncology Drugs: What You Need to Know
AnalysisOncologyApr 29, 2026

SFDA Expedited Review Oncology Drugs: What You Need to Know

Learn about the SFDA's expedited review for oncology drugs, including Pembrolizumab, and how it impacts patient access to essential cancer treatments.

Dr. Grace Tan
Alzheimer's Clinical Trial Failures: Impact on US Market & Investment
AnalysisAlzheimer's diseaseApr 29, 2026

Alzheimer's Clinical Trial Failures: Impact on US Market & Investment

This article examines the implications of recent Alzheimer's clinical trial failures on the US market and investment trends, focusing on drugs such as Aducanumab.

Dr. Grace Tan
Argo Biopharma Doses First Patient in Phase I Trial of siRNA Therapy BW-50218 for TTR-Related Disease
NewsApr 29, 2026

Argo Biopharma Doses First Patient in Phase I Trial of siRNA Therapy BW-50218 for TTR-Related Disease

Argo Biopharma begins Phase I clinical trial of BW-50218, an siRNA therapeutic targeting transthyretin protein for rare disease treatment in Australia.

Dr. Grace Tan
Jyong Biotech Advances Market Access Strategy for Botanical Drug Botreso® and PCP Pipeline
NewsApr 29, 2026

Jyong Biotech Advances Market Access Strategy for Botanical Drug Botreso® and PCP Pipeline

Jyong Biotech (NASDAQ: MENS) updates market access strategies for botanical drugs Botreso® and PCP, establishing competitive advantages in plant-derived therapeutics.

Dr. Grace Tan
NMPA Conditional Approval Pathway: Accelerating Innovative Oncology Drug Access in China
AnalysisOncologyApr 28, 2026

NMPA Conditional Approval Pathway: Accelerating Innovative Oncology Drug Access in China

The NMPA Conditional Approval Pathway is transforming access to innovative oncology drugs such as [Drug Name], expediting their availability for patients in China.

Dr. Grace Tan
Automation Transforming Eco-Friendly Pharma Packaging
AnalysisApr 27, 2026

Automation Transforming Eco-Friendly Pharma Packaging

Explore how automation is revolutionizing sustainable pharmaceutical packaging. This article covers innovative systems, solutions, and supplier roles shaping eco-friendly packaging in pharma.

Dr. Grace Tan