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
Perspective
REGULATORY

Health Canada Reviewer

We have reviewed your competitors' submissions.

STRATEGY

Pharma Strategist

We have built launch strategies at global pharmaceuticals such as Roche, Amgen, and many more.

EXPERIENCE

Treatment Navigator - Patient Experience

We live what your data only measures.

Services

Regulatory Strategy & Submission Review

We review patient-centricity elements across your NDS, SNDS, and CTA submissions.

  • Patient-reported outcomes justification and selection
  • Plain language summary assessment
  • Patient journey and burden-of-illness narratives
  • Benefit-risk framing from patient perspective
  • Module 2.5 and 2.7 patient voice integration
  • Early screening for patient evidence gaps

Commercial Strategy

We review brand plans, market access strategies, and launch positioning.

  • Patient journey assumption validation
  • Access barrier identification across payers
  • Adherence risk assessment
  • Launch messaging reality check
  • Competitive positioning analysis
  • Revenue leak quantification at friction points

Patient Programs

We review PSPs, educational materials, and support resources.

  • Program enrollment barrier analysis
  • Material readability and comprehension assessment
  • Consent form usability review
  • Digital tool functionality testing
  • Healthcare provider resource evaluation
  • Patient insights don't matter if they don't translate to engagement and ROI
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

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.

Toronto, ON

Or email directly: info@orphiva.ca