Our Story
From PV Specialist
to Global CRO.
Every great compliance partner starts by solving one hard problem well. Vigilare Biopharma began as a focused pharmacovigilance consultancy, and grew into an integrated global CRO because our clients kept asking us to take on more of their regulatory burden.
2014Founded
Founded in 2014
A Simpler Way to Manage Compliance
Vigilare Biopharma was founded in 2014 with a simple goal: to make pharmacovigilance and regulatory compliance less fragmented for pharma and biotech companies.
What started as a small drug safety team has since scaled into a full-service regulatory and PV consultancy trusted by clients across multiple continents.
- Founded as a specialist pharmacovigilance consultancy
- Grew into integrated regulatory + PV delivery
- Dedicated regional expertise, not one-size-fits-all
- Trusted by clients across four continents
Key Global Milestones
A Decade of Expansion
How Vigilare grew from a PV consultancy into an integrated global CRO.
2014
Founded as a specialist pharmacovigilance consultancy.
2017
Expanded into regulatory affairs and submissions support.
2019
Launched medical writing and regulatory publishing services.
2021
Extended medical device regulatory consulting for FDA and EU MDR.
2023
Reached clients across North America, Europe, the UK and APAC.
Today
Operating as an integrated, global CRO model.
5Major Health Authorities
5Global Regions
ISO9001:2015 Certified
10+Years of Expertise
Where We're Headed
Expansion & Global Growth
We continue to invest in the capabilities that make compliance simpler for our clients.
Expansion Across Markets
As requirements diversified across the USA, EU, UK, Canada and Australia, we built dedicated regional expertise — so clients enter new markets with a partner who already knows the terrain.
Our Vision for Growth
We continue investing in regulatory intelligence, quality systems, and regional expertise to become the most trusted integrated CRO for pharmacovigilance and regulatory affairs worldwide.
FAQs
Answered. Clearly.
01
How do CRO companies scale globally?
CRO companies typically scale globally by building regional regulatory expertise, expanding service lines to cover the full product lifecycle, and establishing a presence in key markets such as the USA, the EU, the UK, and APAC.
02
What is an integrated CRO model?
An integrated CRO model combines multiple services — such as pharmacovigilance, regulatory affairs, and medical writing — under one provider, reducing the need for clients to manage multiple vendors.
Related Services
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See how an integrated PV and regulatory partner can simplify compliance across your global markets.