Where patient evidence meets execution. A boutique consultancy for pharmaceutical, biotech, healthcare, and patient advocacy organizations.

Regulatory Strategy · Commercial Planning · Patient Perspective

Work With Us
Expertise
REGULATORY

Health Canada Regulator

We have reviewed submissions from the regulator's desk.

STRATEGY

Pharma Strategist

We have built rare diseases, neuroscience, oncology regulatory and patient engagment strategies at global pharmaceuticals such as Roche, Amgen.

EXPERIENCE

Treatment Navigator - Patient Experience

We live what your data only measures.

What We Do

Health Canada Submission Strategy & Review

We develop comprehensive patient-centered submission strategies and screen for PRO elements.

  • Full regulatory strategy for NDS/SNDS/CTA submissions
  • PRO selection, justification, and integration strategy
  • Module 2.5 and 2.7 patient voice assessment
  • Plain language summary review and optimization
  • Patient journey narratives and burden-of-illness statements
  • Pre-submission screening from regulatory and lived experience perspective

CDA Patient Input Strategy

We assess patient evidence sufficiency and structure patient input for HTA review.

  • Review existing patient data against CDA requirements
  • Patient evidence gap analysis and collection roadmap
  • Structure patient input sections for CDA submissions
  • PRO data integration for HTA use
  • Patient organization partnership strategy for CDA input
  • Patient preference study design guidance

Patient Engagement Design

We design structured patient engagement focused on PROs and regulatory-useful evidence.

  • PRO strategy and implementation frameworks
  • Patient-reported outcomes measurement design
  • Patient engagement approach design (interviews, surveys, advisory boards)
  • Evidence generation frameworks for regulatory use
  • Patient journey mapping for submission integration

Patient Advocacy Partnerships

We work with patient organizations to structure funding proposals and strategic partnerships.

  • Patient organization partnership strategy and landscape assessment
  • Grant proposal structuring for IMC compliance and fundability
  • Consulting for patient organizations seeking industry partnerships
  • CDA patient input collaboration frameworks
  • Patient advocacy training and capacity building

Patient Support & Access Strategy

We design patient support programs (PSP), materials, and access strategies.

  • Patient-facing materials development and review
  • PSP patient experience assessment and improvement
  • Access barrier identification and mitigation strategy
  • Patient advocacy activation for formulary challenges
  • Multi-stakeholder engagement strategy for reimbursement

Strategic Advisory

We provide fractional patient strategy leadership for emerging biotech.

  • Ongoing strategic advisory
  • Patient strategy across regulatory, CDA, and access
  • PRO strategy development and implementation guidance
  • Patient organization partnership facilitation
  • Review of submissions, materials, and patient programs
  • Strategic guidance for all therapeutic area launches
Distinction

We catch failures others miss.

Regulatory

Evidence that looks credible but will be questioned by regulators.

Commercial

Launch assumptions that don't match how people actually use treatments.

Real-World Patient Experience

Materials designed for compliance, not the people using them.

Free 30-Minute Consultation

When the cost of getting it wrong exceeds the investment of getting it right, we should talk.

Book a Call or Send us a message below

Toronto, ON

Or email directly: orphiva@gmail.com