Supporting Medical Device, IVD, Pharmaceutical and Healthcare organisations from Concept to Compliance across national and global regulated markets.
Fiducie Life (FOPL) is registered under MSME, Government of India — combining deep regulatory intelligence with practical, implementation-focused consultancy.
Fiducie Life OPC Pvt. Ltd. (FOPL) is a specialized Regulatory Affairs and Quality Management consultancy dedicated to supporting manufacturers, importers, distributors, and healthcare organisations in achieving regulatory compliance and successful market access.
Established in 2026, we deliver end-to-end regulatory, compliance and quality management solutions across CDSCO, USFDA, CE/MDR, Health Canada, ANVISA, MHLW-PMDA and other global frameworks — with a strong focus on technical excellence, audit readiness and documentation quality.
A trusted global consulting partner enabling compliant, high-quality healthcare products across all regulated markets.
Structured, scalable regulatory solutions that accelerate market access and build sustainable compliance cultures.
From initial gap assessment to global market authorization — we handle every step of your regulatory journey.
End-to-end regulatory strategy, licensing, and market authorization for medical devices and IVDs across national and global regulated markets.
Implementation, assessment and continuous improvement of ISO-aligned quality management systems tailored to your operational needs.
Precision preparation and management of technical files, dossiers, and regulatory submissions aligned with global regulatory expectations.
Structured mock audits, gap analysis, CAPA management and compliance monitoring to keep your organisation inspection-ready.
Strategic guidance for CE marking, MDR compliance, notified body coordination and EU market entry for medical devices and IVDs.
Manufacturing license support, GMP compliance, product registration and regulatory submission for pharma, cosmeceuticals and food products.
We provide strategic consultancy across all major regulated markets — helping you achieve market authorization wherever your products need to reach.
A structured, collaborative methodology that delivers results at every stage of your regulatory journey.
What sets us apart in a complex, high-stakes industry where the right guidance makes all the difference.
Deep expertise in medical devices, IVDs and healthcare products — not a generalist firm. We know the nuances that matter.
From initial gap assessment through market authorization and post-market surveillance — one partner for the entire journey.
Multi-jurisdictional expertise covering India, USA, EU, Canada, Australia, Japan, Brazil and emerging markets.
We don't just advise — we implement. Practical, actionable solutions that create measurable compliance outcomes.
We build a culture of continuous compliance in your organisation, not just one-time audit preparation.
Your business goals drive our approach. Strict confidentiality, transparent communication and long-term partnership.
Regulatory delays cost money. We are committed to structured timelines and efficient project delivery.
We design compliance systems built for the long term — not patches, but robust frameworks that scale with your business.
Regulatory and quality management expertise spanning the full spectrum of healthcare product sectors.
Partner with Fiducie Life for strategic regulatory affairs and quality management solutions tailored to your organisation's needs and target markets.
Our regulatory experts are ready to assess your compliance requirements and provide tailored guidance for your specific products and target markets.
Your enquiry has been received. Our team will contact you within 24 business hours.
A specialized regulatory affairs and quality management consultancy built on a foundation of technical excellence, professional integrity and global regulatory intelligence.
Fiducie Life OPC Pvt. Ltd. (FOPL) was established in 2026 and is registered under the Micro, Small & Medium Enterprises (MSME), Government of India. We are a specialized Regulatory Affairs and Quality Management consultancy dedicated to supporting manufacturers, importers, distributors and healthcare organisations.
Our name, "Fiducie," reflects the French and Latin root for trust — at the core of everything we do. We believe that compliance is not just a regulatory obligation, but a commitment to patient safety, product quality and sustainable business growth.
We assist organisations in achieving regulatory compliance, quality excellence and successful market access across national and global markets — with a commitment to adhering to all applicable statutory, regulatory and quality management system requirements.
Our objective is to simplify regulatory and QMS challenges through structured, practical and compliance-oriented solutions that enable the timely placement of quality medical devices and pharmaceutical products in national and international markets.
Maintaining the highest standards of technical accuracy, regulatory knowledge and submission quality in everything we deliver.
Your business information and strategic plans are held in strict confidence. Trust is the foundation of every client relationship.
Regulatory submissions and QMS documentation prepared with meticulous precision to meet the most stringent requirements.
Experienced professionals who bring both regulatory intelligence and practical implementation capability to your challenges.
We stay ahead of evolving regulations and continuously refine our methodologies to deliver better outcomes for clients.
Building compliance systems that grow with your business — not short-term fixes, but long-term regulatory resilience.
Let's discuss how we can support your regulatory affairs and quality management needs.
Comprehensive regulatory affairs and quality management solutions — from initial compliance assessment to global market authorization and beyond.
End-to-end regulatory strategy, licensing and market authorization for medical devices and IVDs across national and global regulated markets.
Establishing, implementing, and continually improving effective quality management systems aligned with international standards.
Structured regulatory guidance, technical documentation support and QMS readiness for CE marking and EU market access.
Strategic consultancy for organizations seeking compliance with USFDA requirements for medical devices and healthcare products.
Building a sustainable culture of audit readiness through structured assessments, training and compliance monitoring.
Precision preparation, review and management of technical documentation and regulatory dossiers for global submissions.
Manufacturing license support, GMP compliance and regulatory submission services for pharma, cosmeceuticals and food products.
Every organisation's regulatory journey is unique. Let's discuss your specific product, market and compliance requirements.
Regulatory and quality management consultancy across all major regulated markets — supporting your global market access strategy with jurisdiction-specific expertise.
From India to the USA, EU to APAC — we bring jurisdiction-specific regulatory knowledge to every engagement.
Comprehensive support for CDSCO licensing, device classification, market authorization and regulatory compliance under India's Medical Devices Rules 2017 and Drugs & Cosmetics Act.
Strategic support for USFDA compliance including QMS regulation, 510(k) documentation, inspection readiness and 21 CFR Part 820 alignment for medical devices.
Full CE certification support covering MDR/IVDR compliance, technical documentation, notified body coordination and post-market surveillance requirements.
Regulatory support for Health Canada compliance under the Medical Device Regulations, including device licensing, technical documentation and QMS requirements.
ARTG registration support, TGA compliance guidance and technical documentation for medical devices and therapeutic goods under the Australian regulatory framework.
ANVISA regulatory support including device registration, RDC compliance, technical dossier preparation and compliance verification for the Brazilian healthcare market.
Documentation support and compliance verification for MHLW-PMDA requirements, helping organizations navigate Japan's Pharmaceutical and Medical Device Act.
Strategic regulatory guidance for APAC, LATAM and African markets — including multi-market regulatory strategy, dossier adaptation and compliance planning for emerging regulated markets.
We also support WHO-Prequalification of products — helping manufacturers meet the internationally recognized standard that enables access to global procurement programmes and international markets.
Our regulatory experts can provide a tailored strategy for your target jurisdiction. Let's identify the fastest, most efficient path to market.
Deep regulatory expertise across the full spectrum of healthcare product industries — understanding the unique compliance challenges of each sector.
Comprehensive regulatory support for Class A through Class D medical devices — from CDSCO licensing and CE certification to USFDA compliance and global market authorization. We support the entire device lifecycle from design through post-market surveillance.
Specialist regulatory and QMS support for IVD manufacturers navigating CDSCO requirements, CE IVDR compliance, and global IVD registration pathways. Our team understands the specific performance study, labeling and classification requirements for diagnostic products.
End-to-end support for pharmaceutical manufacturers including manufacturing license applications, GMP compliance, product registration, technical dossier preparation and regulatory submissions for national and international markets including USFDA, EU and CDSCO.
Regulatory consultancy for cosmeceutical products navigating the complex boundary between cosmetics and pharmaceuticals — including product categorization, labeling compliance, registration support and market authorization across multiple jurisdictions.
Regulatory and compliance support for nutraceutical manufacturers across India and global markets — including product classification, manufacturing license support, quality documentation and registration with relevant regulatory authorities.
Complete QMS implementation, audit readiness and regulatory compliance support for healthcare product manufacturers — from greenfield facility setup through ISO 13485 certification and ongoing compliance management.
Regulatory support for healthcare product importers and exporters navigating CDSCO import licensing, free sale certificates, product registration in target markets and documentation requirements for cross-border healthcare trade.
QMS alignment, GMP compliance and regulatory support for CMOs seeking to meet client quality requirements and regulatory expectations across multiple product categories and markets — including supplier audit support and quality agreement guidance.
Don't see your sector listed? We work across the broader healthcare ecosystem. Contact us to discuss how we can support your specific regulatory needs.
Ready to accelerate your regulatory journey? Our experts are here to discuss your requirements and provide tailored guidance.
Medical Devices Regulatory Affairs & Quality Management Consultancy. We respond to all enquiries within 24 business hours.