About RegAscent

Company

RegAscent is a founder-led regulatory consultancy serving early-stage pharma, biotech, and medtech innovators.

We specialize in engineering defensible regulatory strategies, submission-grade documentation, and globally aligned compliance systems — without enterprise overhead or junior handoffs.

Every engagement is executed directly under RAC-certified leadership. The result is strategic continuity, documentation integrity, and regulatory defensibility on every deliverable.

No outsourcing. No dilution. No compliance shortcuts.

Meet The Founder

Shaheen Fathima Abdul Jamal Nazar, RAC
Founder & CEO, RegAscent

RegAscent was founded on a straightforward premise: early-stage life sciences teams deserve senior-level regulatory expertise — not a junior consultant working from a template, and not a large firm that bills for overhead and delivers a team they never met.

Shaheen brings 4+ years of hands-on regulatory affairs experience across pharmaceutical, biologics, and medical device development — spanning IND/CTA, NDA/ANDA, eCTD publishing, Module 2/3 documentation, labeling compliance, EU PIPs, US Pediatric written requests, MDR/IVDR technical files, and QA system development.

Her framework experience spans FDA, Health Canada, EMA, CDSCO, GCC, TGA, and MHRA — giving clients access to globally calibrated regulatory strategy without engaging multiple regional consultants.

Credentials:
— RAC-Drugs Certified, RAPS (2026–2029)
— ICH-GCP Certified (valid through 2028)
— FDA-trained across drug safety, labeling, REMS, and biosimilars
— Top Rated Plus on Upwork | 100% Job Success Score

Why RegAscent

Boutique Execution. Global Standard.

— Direct founder involvement in every engagement — not delegated, not outsourced
— RAC-certified expertise applied to every deliverable
— Authority-aligned documentation built for how regulators actually review
— Startup-calibrated execution speed without compliance shortcuts
— Global framework coverage without regional consultant overhead

Regulatory confidence is earned through structure — not optimism.