StandPoint Health Research

About Us
StandPoint Health Research is a regulatory affairs and vendor management consultancy serving life sciences organizations across the Canada and U.S. We help biopharma teams navigate early development and regulatory complexity with clarity, compliance, and control.

What We Do
• Regulatory Strategy & Submissions
Global and Canadian filings (IND, NDA, ANDA, 510(k), PMA, DIN, DESL), regulatory pathways, and agency interactions.
• Scientific & Regulatory Writing
Protocols, SOPs, investigator brochures, submission dossiers, gap analyses.
• Vendor Oversight
CRO/CDMO/lab selection, qualification, contracts, and ongoing management.
• Operational Support
SOP validation, trial startup readiness, team training, inspection prep.
• Therapeutic & Modality Focus
Oncology, CNS, metabolic, dermatology; small molecules, biologics, ATMPs, RNA, digital health.

Founder Expertise
Dr. Rashmi Tiwari, Ph.D., CCRP is a regulatory‑affairs and vendor‑management specialist with 15 years’ experience spanning academia, pharma, and CROs. She guides early‑stage biopharma teams through FDA / Health Canada pathways, clinical‑trial applications, GxP and quality‑system compliance, while ensuring strategic, efficient execution across diverse therapeutic areas.

Thank you,

Rashmi Tiwari, PhD, CCRP
Founder | Principal Consultant
| Email: rtiwari@standpointhealth.com
www.standpointhealth.com | linkedin.com/in/rashmitiwari-phd-ccrp