Pharmacovigilance, Medical Information & Regulatory services partner
Medifodil Smart Pharma Solutions is a global CRO and healthcare technology partner providing end to end solutions across Pharmacovigilance, QPPV, Medical Information (MICC), Clinical Research, Regulatory Affairs, Medical Writing, BA/BE Studies, Preclinical Research, and Formulation R&D. We combine scientific expertise, regulatory excellence, and technology driven innovation to help pharmaceutical, biotechnology, medical device, and healthcare organizations accelerate product development, maintain the highest standards of quality and compliance, and deliver safe, effective therapies to patients worldwide. Our commitment to client success, operational excellence, and long term partnerships makes us a trusted partner throughout the product lifecycle.
Drug development lifecycle
From molecule to market — and beyond
Medifodil supports sponsors from Preclinical Research right through to Post Marketing Surveillance, with integrated scientific, regulatory and safety expertise at every stage.
- 01
Discovery & Development
Target identification, lead optimisation and early candidate selection.
Sponsor led - 02
Preclinical Research
Toxicology, ADME, analytical method development and IND enabling studies.
Medifodil support - 03
Clinical Development
Protocol design, Phase I–IV monitoring, BA/BE studies and medical writing.
Medifodil support - 04
Regulatory Approval
CTD/eCTD dossiers, IND/NDA/ANDA submissions and health authority responses.
Medifodil support - 05
Post Marketing Surveillance
Pharmacovigilance, QPPV oversight, signal detection, PSUR/PBRER and MICC.
Medifodil support
Medifodil coverage
Preclinical → Clinical → Regulatory → Post Marketing Surveillance
Global Healthcare Partner
Built on Quality. Driven by Innovation. Guided by Integrity. Committed to Compliance.
Medifodil Smart Pharma Solutions is a global CRO and healthcare technology partner serving pharmaceutical, biotechnology, medical device, and healthcare organizations worldwide. Everything we do is guided by our four core principles — Quality, Compliance, Integrity, and Innovation. By combining scientific expertise, regulatory excellence, and technology driven solutions, we help our clients accelerate product development, ensure patient safety, maintain global regulatory compliance, and achieve successful outcomes with confidence.
Our mission
To empower pharmaceutical, biotechnology, and medical device organizations with integrated preclinical, clinical, pharmacovigilance, regulatory, BA/BE, and formulation R&D solutions — combining scientific expertise, regulatory excellence, and digital innovation to deliver safe, effective, and compliant therapies to patients worldwide.
Our vision
To become one of the world's most trusted life sciences organizations — redefining how healthcare services are delivered through advanced technologies, experienced professionals, and intelligent workflows that create lasting impact for clients, regulators, and patients globally.
Why Medifodil?
Four principles that define how we work with every sponsor.
Scientific rigor
Every deliverable is grounded in evidence, therapeutic area expertise, and quality by design discipline.
Global reach
Regulatory fluency across US, EU, and emerging markets — one partner, worldwide coverage.
Partnership model
We operate as an extension of your team with transparent communication and milestone driven delivery.
Technology enabled
AI assisted monitoring, RPA in case processing, and modern analytics that accelerate outcomes without cutting corners.
Our services
Integrated capabilities spanning the entire drug development and safety spectrum.
Pharmacovigilance
End-to-end drug safety monitoring, ICSR case processing, aggregate reporting (PSUR/PBRER/PADER), risk management, signal detection, and QPPV services — our core practice.
Learn moreMICC — Medical Information
24/7 Medical Information Contact Center delivering compliant medical enquiry handling, adverse event intake, and exceptional customer experience worldwide.
Learn moreRegulatory Services
Regulatory strategy, dossier authoring, eCTD submissions, health authority liaison, and lifecycle management for global markets.
Learn moreClinical Trials
Protocol design, site monitoring, risk-based monitoring, patient safety oversight, and clinical operations support across phases I–IV.
Learn morePreclinical Research
Pharmacology, toxicology, safety assessment, and IND-enabling studies that build a strong foundation for clinical development.
Learn moreFormulation R&D
Preformulation, formulation development, stability studies, and scale up for small molecules and complex dosage forms.
Learn moreBA/BE Monitoring
Bioavailability and bioequivalence study oversight, data integrity checks, and PK analysis coordination.
Learn moreIntelligent automation across the drug lifecycle
We embed artificial intelligence and machine learning into every workflow — from early discovery to post market safety — to accelerate timelines, sharpen decisions, and elevate patient outcomes without compromising compliance.
AI driven signal detection
Machine learning models mine FDA AERS, EudraVigilance, and literature streams to surface emerging safety signals earlier than manual review alone.
RPA case processing
Robotic process automation handles repeatable ICSR data fields while our scientists focus on validation and clinical narrative — accuracy at scale.
Predictive clinical analytics
AI assisted patient recruitment, risk based monitoring, and real time data validation keep every trial on time, on budget, and inspection ready.
Regulatory intelligence
NLP powered dossier authoring, automated compliance checks, and lifecycle intelligence keep submissions aligned with evolving global standards.
About us
About Medifodil Smart Pharma Solutions
Medifodil Smart Pharma Solutions Pvt. Ltd. is a global healthcare technology, analytics, and CRO serving pharmaceutical, biotechnology, medical device, and healthcare organizations across the drug and device lifecycle. Founded and led by seasoned professionals with experience across leading global CROs and biopharmaceutical innovators, Medifodil is committed to accelerating healthcare innovation while ensuring the highest standards of quality, compliance, and patient safety.
With end to end capabilities across the entire product lifecycle, Medifodil delivers integrated solutions in Pharmacovigilance, Clinical Research, Preclinical Research, Regulatory Affairs, Medical Writing, Medical Information, Quality Assurance, Bioavailability/Bioequivalence (BA/BE) Studies, Formulation Research & Development, and Technology Driven Healthcare Solutions. By combining scientific excellence, regulatory expertise, and digital innovation, the company enables clients to bring safe, effective, and compliant therapies to global markets with confidence.
Driven by a culture of innovation and operational excellence, Medifodil partners with sponsors of every size to simplify complex development pathways, optimize regulatory strategy, strengthen patient safety, and accelerate commercialization — with transparency, agility, scientific integrity, and an unwavering commitment to measurable value.
With a vision to become one of the world's most trusted life sciences organizations, Medifodil continues to invest in advanced technologies, highly experienced professionals, and intelligent workflows that redefine how healthcare services are delivered — creating lasting impact for clients, regulators, healthcare professionals, and patients worldwide.
Join our team
We are always looking for talented professionals — scientists, clinicians, regulatory experts, and operators — who share our commitment to patient safety and scientific rigor. Send us your resume and let's start a conversation.
Send your resume and a short note to careers@medifodil.com
Get in touch
Tell us about your project. We will respond within one business day to discuss how we can support your program.
Email us
info@medifodil.comCall us
+91 90321 15695Hyderabad, India
3rd Floor, Satya Enclave,
KPHB Road No. 1, Kukatpally,
Hyderabad, Telangana 500072, India
Edison, New Jersey
Ashley Road,
Edison, New Jersey 08817,
United States of America
Global footprint
Serving sponsors across continents
Offices and active engagements across India, USA, Canada, and Dubai — supporting sponsors across North America, Europe, Middle East, and Asia Pacific.
Expanding to Australia, Japan and more.