Regulatory Affairs — Life Sciences & MedTech
Compliant Across
the Full Lifecycle.
Regulatory requirements don't end at product launch; they evolve throughout the lifecycle. We provide regulatory affairs support across pharma, biotech, and medical devices, from initial strategy through post-market changes.
FullLifecycle
Overview
Lifecycle Regulatory Management
Regulatory affairs manage the relationship between your company and health authorities — developing submission strategy, preparing documentation, and keeping products compliant throughout their commercial life.
Our specialists maintain up-to-date knowledge across the FDA, EMA, MHRA, Health Canada, and TGA, as well as device-specific frameworks such as the EU MDR and IVDR.
- Regulatory strategy for new product development
- Submission planning and dossier preparation
- Variations, renewals and label change management
- Regulatory due diligence for licensing and M&A
What We Deliver
Pharma, Biotech & MedTech Coverage
Regulatory support that adapts to your product, therapeutic area, and stage of growth.
Regulatory Strategy Development
Strategy for new product development across pharma, biotech and devices.
Submission Planning & Dossiers
Submission planning and dossier preparation to agency standards.
Variations, Renewals & Labels
Variation, renewal, and label-change management post-approval.
Post-Market Surveillance
Post-market surveillance and reporting obligations tracking.
Regulatory Due Diligence
Due diligence for licensing and M&A transactions.
5Major Health Authorities
5Global Regions
ISO9001:2015 Certified
10+Years of Expertise
Why Vigilare
Cross-Functional Coordination
Regulatory that connects to your safety, writing and quality functions.
Global Compliance Expertise
Current knowledge across FDA, EMA, MHRA, Health Canada, TGA, EU MDR and IVDR.
One Audit-Ready Trail
Submissions supported by consistent documentation across every function.
Lifecycle, Not Just Launch
Variations, renewals and label changes filed correctly and on time.
Named Senior Leads
Senior oversight on every engagement, from strategy to post-market.
Our Approach
Regulatory That Evolves
A lifecycle model that keeps your compliance strategy aligned as regulations change.
01
Strategise
Regulatory strategy development for the product and target markets.
02
Prepare
Submission planning and dossier preparation.
03
Submit
Filing and agency interaction across regions.
04
Maintain
Variations, renewals and label change management.
05
Monitor
Post-market surveillance and reporting obligations.
FAQs
Answered. Clearly.
01
What does regulatory affairs do?
Regulatory affairs manage the relationship between a company and health authorities — developing submission strategy, preparing regulatory documentation, and ensuring products remain compliant throughout their commercial lifecycle.
02
Why is the regulatory lifecycle important?
Lifecycle management ensures that as products are updated, relabeled, or expanded into new markets, all necessary approvals and notifications are filed correctly and on time, avoiding compliance gaps or enforcement action.
Related Services
Explore the Full Practice
Get guidance on your product's regulatory lifecycle.
From first strategy to post-market change management, one accountable regulatory partner across every market.