Expertise
GMP Facility Design
End-to-end facility design support — room classification, personnel and material flow, and contamination control — informed by direct experience building an EU GMP site from the ground up, including the mistakes worth avoiding the second time.
QA Systems & Audits
EU GMP and GACP audits, equipment qualification and process validation, and QMS design and implementation — plus CTD/dossier writing and hands-on support building your internal QA team, so compliance doesn't depend on an outside consultant indefinitely.
Regulatory Pathway & Market Access Strategy
Regulatory Pathway & Market Access Strategy: One method, applied across every regulated sector: stage-gated pathway mapping for market access — whether entering a new domestic category or exporting across borders — entry requirements, evidence, and known failure points at every gate.
Why Solvara
Built by someone who's operated these systems from the inside
Most regulatory consultants approach compliance as a checklist exercise. Solvara was founded on the opposite premise — direct, hands-on experience across the full manufacturing lifecycle, from analytical bench work through licensing, facility build-out, and cross-border GMP release.
That operator's perspective shapes every engagement: identifying not just what's missing on paper, but what actually breaks in practice.
Let's start a conversation
Let's map your path to market.
Whether it's a single audit or a full export pathway strategy, the first conversation is free — and usually the most useful hour you'll spend this quarter.
Contact us at info@solvara.ca