Regulatory depth across every major agency
FDA EMA MHRA TGA CDSCO SFDA
10+
Years of
Mastery
Years of
Mastery
Need a roadmap?
Talk to a senior expert — not a sales rep.
Why Vigilare
Caring for Your Therapy with Integrity & Precision
Most life sciences companies juggle a CRO for trials, a separate firm for submissions, another for pharmacovigilance, and a market-access consultant brought in too late. The result: evidence gaps, delays, and HTA dossiers that were never designed with payers in mind. Vigilare was built to close that gap.
Integrated Lifecycle Model
Clinical, safety, regulatory, and market access run as one coordinated programme — one team, one accountability chain, no silos.
Evidence-to-Reimbursement™
HEOR and HTA strategy embedded into clinical design from Phase II — data built to satisfy regulators and payers from Day 1.
Global Reach, Local Depth
US, EU, UK, India, Australia & MEA — navigated with region-specific regulatory nuance, not generic frameworks.
Services
One Partner. Every Stage. Every Market.
Five integrated service pillars — architected to work independently or as a seamless end-to-end engagement, all delivered with ISO-certified quality and regulatory precision.
01
Pharmacovigilance & Drug Safety
ICSR processing, signal detection, PSUR/PBRER, PV system setup, risk management plans. ICH E2E/E2F compliant, globally scalable.
02
Regulatory Affairs
NDA, BLA, MAA, ANDA submissions. Regulatory intelligence, gap analysis, medical writing, and eCTD publishing across all major agencies.
03New
Clinical Development (CRO)
Phase I–IV trial management, clinical data management (CDISC/CDASH), biostatistics & SAS programming, and patient recruitment.
04New
Market Access & HEOR
HTA dossiers (NICE, HAS, IQWiG, PBAC), HEOR study design, value dossiers, payer engagement, RWE strategy and early access programs.
05
Medical Device Regulatory
CE-MDR, FDA 510(k)/PMA, CDSCO registrations, device labeling, IFU documentation, technical file development and MOH liaison.
06
Quality & Compliance
GxP auditing, QMS design & SOP development, inspection-readiness programs, mock FDA/EMA audits, and CAPA management.
0+Years Since 2014
0+Global Markets Served
0Major Regulatory Agencies
0Industry Verticals
Industries
Built for the Complexity of Your Industry
Our integrated model is tailored for three distinct life-sciences verticals — each with its own regulatory landscape, clinical complexity, and market-access dynamics.
Pharmaceutical & Biotech
From IND-enabling studies and Phase I through global NDA/MAA submissions, post-market PV, and HTA strategy — for innovators who need end-to-end support without enterprise overhead.
Medical Devices & IVD
CE-MDR transition, FDA 510(k) and PMA submissions, CDSCO device registrations, clinical evaluation reports, and post-market clinical follow-up across jurisdictions.
Rare Disease & Specialty
Orphan drug designations, breakthrough therapy programs, adaptive trial design, HEOR for ultra-rare indications, and named-patient & early-access strategies.
Our Process
From First Call to Final Approval
Every engagement follows our 5-stage Evidence-to-Reimbursement™ methodology — de-risking your programme at every phase.
01
Scoping & Intelligence
Map target markets, identify regulatory pathways, and build a gap-free roadmap.
02
Evidence Architecture
Design protocol & SAP with the market-access dossier already in mind.
03
Submission & Safety
ISO-certified eCTD submission, ICSR/PSUR PV, and signal detection.
04
Market Access & HTA
Value dossiers, HEOR models, and HTA submissions to NICE, HAS, PBAC.
05
Lifecycle Management
Post-market surveillance, label extensions, RWE, and renegotiations.
Global Reach
Regulatory Expertise Where It Matters Most
We serve clients across five regulatory regions with specialist, in-country expertise in the requirements, timelines, and nuances of each jurisdiction.
United States
FDA · CDER · CDRH · CBER
NDA, BLA, 505(b)(2), 510(k), PMA, and IND submissions.
European Union
EMA · National CAs
MAA, CP/MRP/DCP, CE-MDR, and PIP strategy.
United Kingdom
MHRA
Post-Brexit UK submissions and the UKCA / CE-MDR device pathway.
India
CDSCO
Drug & device registrations, clinical-trial approvals, and PV.
Australia / ANZ
TGA
TGA registrations, ARTG submissions, and PBAC HTA dossiers.
Middle East & Emerging
SFDA · MOH
Gulf-state registrations and GCC regulatory harmonisation.
Testimonials
What Partners Say About Working With Us
Read how regulatory, clinical, and market-access leaders describe their engagements with Vigilare.
Latest Insights
Regulatory Intelligence & Market-Access Strategy
From FDA-guidance decoding to HEOR deep dives — our experts publish the thinking that matters to life-sciences decision-makers.
White Paper
The HEOR Integration Imperative: Why Market Access Starts at Phase II
Guide
CE-MDR Transition Checklist: 12 Critical Actions for Device Manufacturers
Webinar
Pharmacovigilance in 2025: New ICH Expectations for Your PV System
Blog
CDSCO's New Drug Import Regulations: What Pharma Exporters Need to Know
Get Started
Build Your Evidence-to-Reimbursement™ Pathway
Whether you're preparing your first IND, navigating a CE-MDR transition, or designing a global market-access strategy — our integrated team is ready to map your pathway.
Responded to within 1 business dayA real expert conversation, not a generic proposal.
Senior expert, not a sales callSpeak directly with a regulatory or clinical lead.
Confidential under NDA if requiredYour programme details stay protected.
Book a Strategy Consultation
Tell us about your programme and we'll match the right team.
FAQs
Frequently Asked Questions
The questions life-sciences decision-makers ask us most often.
01
What is Vigilare Biopharma's core service offering?
Vigilare is an ISO 9001:2015 certified integrated CRO and regulatory partner offering five pillars: Pharmacovigilance & Drug Safety, Regulatory Affairs, Clinical Development (CRO), Market Access & HEOR, and Medical Device Regulatory — serving pharma, biotech, and MedTech across 30+ countries.
02
How is Vigilare different from a traditional CRO?
Unlike CROs focused only on trial execution, Vigilare connects clinical evidence, regulatory strategy, pharmacovigilance, and market access under one roof. Our Evidence-to-Reimbursement™ approach ensures your data satisfies both regulators and payers from the beginning — not as an afterthought.
03
Which regulatory agencies does Vigilare have expertise in?
Our teams have direct submission experience with the US FDA (CDER, CDRH, CBER), EMA, MHRA (UK), TGA (Australia), CDSCO (India), and several Gulf-state authorities — supporting NDA, BLA, MAA, ANDA, 510(k), PMA, and CE-MDR pathways.
04
Does Vigilare work with emerging biotech companies?
Yes. Vigilare was designed for emerging and mid-size pharma and biotech who need enterprise-grade regulatory and clinical expertise without the cost and complexity of large global CROs — with flexible engagement models from project scopes to full-programme partnerships.
05
What is pharmacovigilance and how does Vigilare support it?
Pharmacovigilance is the science of monitoring, detecting, and preventing adverse effects of medicines. Vigilare provides ICSR processing, signal detection, PSUR/PBRER preparation, risk management plans, PV system setup, QPPV services, and EU/US PV compliance.
06
Can Vigilare help with HTA submissions and market access?
Absolutely. Our Market Access & Evidence team specialises in HEOR study design, HTA dossiers for NICE, HAS, IQWiG, and PBAC, global and country value dossiers, payer engagement, and real-world evidence to support post-approval access and label extensions.
Ready to bring your therapy to patients — on time, on label, on market?
No obligation. No generic proposals. Just a real expert conversation about your programme.
ISO 9001:2015 Certified
Responded within 1 business day
Confidential under NDA