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Integrated Life Sciences Partner · Since 2016

Pharmacovigilance.
Medical Affairs. Regulatory.
AI Technology.

From first IND through post-marketing surveillance — one integrated team across five global offices. Built for pharmaceutical companies that cannot afford gaps in quality, compliance, or delivery.

Our Service Model

Four Integrated Capabilities. One Accountable Partner.

Fidelity operates across the complete drug development and commercialisation lifecycle — eliminating handover gaps, fragmented accountability, and siloed expertise.

Drug Safety & Pharmacovigilance

ICSR processing, aggregate reporting, signal detection, RMP/REMS. Inspection-ready, always.

Medical & Scientific Affairs

Medical Information Call Center (MICC), medical writing, scientific communications, KOL engagement.

Regulatory Affairs

IND, NDA, BLA, MAA submissions; labeling lifecycle; eCTD publishing and regulatory intelligence.

Technology, Data & AI

Safety database implementation, validated data migration, technology-enabled workflows, and AI on the roadmap.

🔗
Single Accountable Partner
Drug Safety, Medical Affairs, Regulatory & Technology — one integrated team, zero handover gaps
🌍
Global Delivery Coverage
Onshore in US, UK & Canada · 24-hour offshore delivery from India · cost-optimised, quality-assured
⚡
Technology-Enabled Delivery
Structured workflows and validated tools across all service lines · AI-enhanced capabilities on the roadmap
🏆
Inspection-Proven Quality
FDA · MHRA · BfArM · Health Canada · COFEPRIS — multiple audits, zero critical findings
Ten-Year Track Record

Numbers That Define a Decade of Excellence.

Built over ten years of integrated pharmacovigilance operations across pharma, biotech, and generics clients globally.

1M+
ICSRs Processed
End-to-end intake, coding, and regulatory submission globally
5,000+
Aggregate Reports
PSURs, PBRERs, PADERs, DSURs — zero deadline breaches
1000+
Risk Management Plans
EU RMP and US REMS across oncology, rare disease, biologics
15+
Regulatory Inspections
FDA, MHRA, BfArM, Health Canada, COFEPRIS — zero critical findings
Regulatory Inspection Record

Inspected by the World's Most Demanding Regulators.

Fidelity has been audited by the world's most demanding regulatory authorities — each time emerging with zero critical findings. Our quality systems are inspection-ready every day of the year.

04
times inspected
USFDA
✓ No 483 Issued
Zero observations across every audit
02
times inspected
MHRA UK
✓ Zero Observations
Full GVP inspection with no CAPAs required
03
times inspected
BfArM Germany
✓ No Major Findings
No critical or major observations across all three audits
02
times inspected
Health Canada
✓ No Major Findings
Canadian regulatory inspection — no major findings
Also Inspected By →
COFEPRIS (Mexico) SAHPRA (South Africa) EAEU (Eurasia) DCGI (India) Multiple other authorities Multiple Inspections · Zero Critical Findings
What Our Clients Say

Trusted by Global Pharma & Biotech.

"

The professionalism and compassion demonstrated by their staff have truly set them apart. The comprehensive pharmacovigilance solutions provided by Fidelity have exceeded our expectations.

KP
Key Contact Person
Multinational Pharmaceutical Group
"

Fidelity demonstrated an in-depth understanding of the PV landscape. Their global-quality standards and commitment to regulatory requirements gave our team complete confidence.

PV
Deputy PV Responsible Person
Top 10 Indian Pharma — Global Presence
"

Highly experienced, trustworthy, and professional case processing and aggregate report writing teams — managing challenging situations effortlessly. We are absolutely satisfied.

DS
Head — Drug Safety & Medical Affairs
Indian Global Pharmaceutical Company
"

In July 2020, Fidelity began processing cases. The team handled all cases within deadlines. The project leader was very responsive. Quality and compliance were exactly as per expectations.

GH
Global Head — Pharmacovigilance
Top 5 US Generic Company — 30+ Countries
"

Fidelity's passion for their projects, combined with the strong domain expertise of the Founder, sets them apart from other CROs. They delivered all our projects within strict timelines.

MD
Managing Director
Indian-based Pharmaceutical Company
"

Fidelity's clinical team is devoted, approachable, and has a deep understanding of designing and executing respiratory clinical trials. Strong execution, high-quality work, on-time delivery.

RC
Global Head — Respiratory Clinical Research
Top 10 Indian Pharma — Global Presence

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