Regulatory Affairs Consulting
RIMS management, GUDID and EUDAMED submissions, UDI compliance, eIFU gap analysis, and global regulatory database maintenance across US, EU, and Swiss markets.
Learn MoreDharma Consulting delivers independent, remote regulatory affairs and quality consulting to medical device and pharmaceutical companies — across US, EU, and Swiss markets. We work lean, move fast, and deliver without hand-holding.
Regulatory Services Offered
Global Manufacturing Sites Supported
Remote Delivery — Zero Office Overhead
Active Client Engagements
From RIMS data management to MES implementation, Dharma Consulting handles the regulatory and quality complexity so your team doesn't have to.
RIMS management, GUDID and EUDAMED submissions, UDI compliance, eIFU gap analysis, and global regulatory database maintenance across US, EU, and Swiss markets.
Learn MoreISO 13485-aligned QMS consulting, change control management, process standardization, and quality systems implementation for medical device manufacturers.
Learn MoreTransitioning paper-based batch records to electronic batch records across multi-site global manufacturing — standardized, compliant, and validated.
Learn MoreEUDAMED data submissions, eIFU position paper gap analysis, EU MDR documentation review, and labeling compliance for Class I–III medical devices.
Learn MoreMaintaining audit-ready regulatory trackers, product registration data across global databases, and Agile PLM document flows — with zero tolerance for data errors.
Learn MoreIndependent gap analysis against MDCG guidelines, eIFU requirements, and EU MDR — with structured action plans, SME coordination, and full closure tracking.
Learn MoreWe understand your regulatory landscape, compliance gaps, and immediate priorities in a single focused session. No lengthy onboarding — just clarity.
You receive a clearly defined scope, deliverable list, and timeline. No vague retainers, no hidden hours, no scope creep.
Our consultant takes ownership. Daily timesheet logs, structured progress trackers, and proactive communication — without needing to follow up on us.
Audit-ready documentation, closed trackers, and final deliverables — reviewed together and signed off. Every time.
Most consulting firms build large teams and layer overhead on top. Dharma operates differently — lean, precise, and built for independent delivery.
We don't need daily meetings or status calls. Give us the objective and the tools — we'll build the action plan, execute, and report. Ownership is in our DNA.
Most consultants specialize in one area. Dharma bridges regulatory affairs and quality systems — critical when both functions need to move together.
Deep expertise in FDA, EU MDR, and Swiss MedDO regulations — delivered remotely at a fraction of US consulting day rates. Full EST business hour overlap.
Every tracker, document, and submission is prepared for regulatory scrutiny. We don't just complete tasks — we build compliance assets that hold up under audit.
Dharma Consulting is a lean remote team. We hire people who identify problems, build their own plans, and deliver — without being told to. If that's you, we want to hear from you.
Own regulatory data accuracy, drive EUDAMED submissions, perform eIFU gap analysis, and maintain audit-ready trackers — independently.
Standardize quality processes across 5 global manufacturing sites, own eBR requirements, and drive change control closure — independently.
"Dharma's consultant took ownership of our EUDAMED gap analysis from day one. Zero hand-holding needed — we just reviewed the final tracker and everything was closed."
"Regulatory data accuracy improved significantly after Dharma standardized our GUDID submissions process. Highly recommend for lean compliance teams."
"Their MES process standardization work saved us months of misalignment across our five sites. Professional, precise, and completely self-managed."
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