StandPoint Health Research helps you bring therapies to market- faster & smarter
End-to-end support for early development and regulatory execution in pharmaceuticals, biotech, and natural health products.
From submission strategy to vendor qualification and compliant documentation; we bring clarity and control to complex workflows.

Our Core Services

Regulatory Strategy & Submissions
• IND, NDA, ANDA, 510(k), PMA, NPN planning
• Regulatory pathway selection & health authority communications
• Licensing support (DIN, NPN, DEL/Site, NNHPD, provincial)

Scientific & Regulatory Writing
• Submission-ready dossiers & NPN applications
• Clinical protocols, investigator brochures, SOPs
• Compliance reviews, gap analysis, and audits

Vendor Identification & Oversight
• CRO, CDMO, and lab selection & qualification
• GMP/NHP-compliant vendor management
• Contract negotiation & risk oversight

Operational Support
• SOP development & validation
• Trial readiness & documentation
• Early-stage operational compliance

Therapeutic Areas Supported
Oncology | Cardiovascular | CNS | Dermatology | Endocrinology | Women’s Health | Arthritis | Fatty Liver Disease

Therapeutic Modalities
Small Molecules | Biologics | Advanced Therapies | Vaccines | Drug–Device Combos | Topicals | Digital & RNA Therapeutics | Cell & Gene Therapies | Genome Editing | Controlled Substances/Cannabinoids


Principal Consultant

Dr. Rashmi Tiwari, Ph.D., CCRP, is a regulatory affairs expert and vendor management specialist supporting early-stage biopharma companies. She navigates FDA and Health Canada pathways, CDSA and Cannabis Act compliance, clinical trial applications, GxP systems, and quality standards, delivering strategic, efficient execution across U.S. and Canadian markets. With 15+ years of experience spanning academia, pharma, and CROs, she brings both scientific depth and operational precision. Her expertise extends across oncology, endocrinology, women’s health, CNS, and advanced delivery technologies, with proven strength in controlled-substance programs. She partners with innovators to transform regulatory complexity into clear, compliant, and timely development solutions.


Thank you,

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