Document Purpose:
This Global Regulatory Consulting Fee Schedule provides the standardized hourly rates for OMC Medical’s regulatory affairs consulting services. Rates are categorized by consultant expertise and adjusted for market complexity, local economic conditions, and the requirements of specific national regulatory authorities.
OMC Medical Regulatory Consulting Hourly Rates & Fee Schedule 2025
1. Rate Tiers & Consultant Classification
OMC Medical classifies consultants into tiers based on experience, specialization, and leadership capability in managing medical device and pharmaceutical regulatory projects.
Tier 1: Senior Regulatory Strategist / Principal Consultant
- Profile: 15+ years’ experience in regulatory strategy and high-level negotiations with agencies (e.g., FDA pre-submission meetings, EMA scientific advice). Oversees complex product lifecycles, including novel drugs and Class III/IV medical devices.
- Typical Services: Regulatory strategy development, agency meeting preparation & leadership, gap analysis, due diligence, executive advisory.
Tier 2: Regulatory Affairs Specialist / Manager
- Profile: 5–14 years’ experience in compiling, authoring, and submitting regulatory dossiers (e.g., 510(k), PMA, IND, NDA, MDR Technical Documentation). Manages client communication and ensures submission compliance.
- Typical Services: Submission compilation & authoring, change management assessments, technical file reviews, Q-Sub applications, client liaison.
Tier 3: Regulatory Associate / Analyst
- Profile: 1–4 years’ experience supporting senior consultants with research, documentation, formatting, and managing regulatory databases. Works under supervision for defined tasks.
- Typical Services: Regulatory intelligence research, document publishing & formatting, maintenance of submission trackers, administrative submission support.
2. Country-Specific Hourly Rate Card (USD)
Rates are based on market complexity, regulatory pathways, and administrative burden. All fees are billed in USD.
| Region | Country | Regulatory Authority | Tier 1 ($/hr) | Tier 2 ($/hr) | Tier 3 ($/hr) | Notes |
|---|---|---|---|---|---|---|
| North America | United States | FDA | $375–$450 | $275–$325 | $150–$200 | Premium for complex pathways (PMA, Novel Drugs). |
| Canada | Health Canada | $330–$395 | $245–$295 | $135–$180 | Licensing (MDEL/MDL) vs. Class impacts complexity. | |
| Europe | European Union | EMA & Notified Bodies | $350–$425 | $260–$315 | $140–$185 | Rates vary slightly by member state. |
| United Kingdom | MHRA | $340–$400 | $250–$300 | $135–$175 | UKCA pathway post-Brexit. | |
| Switzerland | Swissmedic | $345–$410 | $255–$305 | $140–$180 | EU MDR mirrored but with national application. | |
| Asia-Pacific | Japan | PMDA | $360–$430 | $265–$320 | $145–$190 | Premium for mandatory consultations. |
| Australia | TGA | $325–$385 | $240–$290 | $130–$175 | Streamlined but specific processes. | |
| China | NMPA | $335–$395 | $250–$300 | $135–$180 | Premium for clinical trial oversight and translations. | |
| South Korea | MFDS | $330–$390 | $245–$295 | $130–$175 | Strict technical review standards. | |
| India | CDSCO | $290–$340 | $210–$260 | $110–$150 | Local liaison fees may be included. | |
| Middle East | Saudi Arabia | SFDA | $320–$380 | $240–$290 | $130–$170 | Premium for mandatory audit support. |
| UAE | MOHAP & DHA | $310–$370 | $230–$280 | $125–$165 | Multiple emirate coordination. | |
| LATAM | Brazil | ANVISA | $315–$375 | $235–$285 | $125–$170 | Complex and lengthy approval process. |
| Mexico | COFEPRIS | $305–$355 | $225–$275 | $120–$160 | Requires local representation. | |
| Argentina | ANMAT | $300–$350 | $220–$270 | $115–$155 | Economic volatility can impact timelines. | |
| Africa | Pan-Africa | Various | $300–$370 | $220–$280 | $115–$165 | Rates vary widely — project-specific. |
| South Africa | SAHPRA | $310–$365 | $230–$275 | $120–$160 | Most mature African regulatory system. |
Note: African projects may be country-specific, regional (e.g., EAC, ZAZIBONA), or multi-country. Rates are baseline and require project-specific scoping.
Terms & Conditions
- Travel Expenses: Travel time billed at 50% of the hourly rate. Direct travel costs billed at cost + 10% admin fee.
- Minimum Engagement: 5-hour minimum for all new project assessments/strategies.
- Retainer Discounts: 5–10% discount for 40+ hours/month under an MSA.
- Currency: All invoices in USD; conversions at prevailing rate, plus bank fees.
- Rate Validity: Valid for proposals within 90 days of effective date; subject to annual review.
- Project-Specific Scoping: LATAM and Africa require detailed scoping before final quote.
OMC Medical Bringing Clarity to Global Compliance www.omcmedical.com | info@omcmedical.com
Why Choose OMC Medical? Navigating the Global Regulatory Landscape with Confidence
At OMC Medical, our global compliance expertise is matched by transparent OMC Medical Regulatory Consulting Hourly Rates, ensuring you receive world-class support with clear, predictable pricing.
1. Unmatched Global Expertise, Local Precision
Deep regulatory knowledge in 50+ markets — from FDA and EMA to SFDA, NMPA, ANVISA, and MFDS — with native-speaking regional experts.
2. Tiered Expertise for Cost Efficiency
Senior strategists for high-level decisions, specialists for submissions, associates for admin — ensuring you only pay premium rates for strategic work.
3. Transparent and Predictable Pricing
Clear global rate card so you can budget with confidence and understand the value per hour.
4. End-to-End Project Management
We handle strategy, submissions, communications, and compliance tracking from start to finish.
5. Proactive Regulatory Intelligence
We anticipate changes, not just react, helping you stay ahead of compliance shifts.
6. Commitment to Your Success
Your timelines are our priority — from first-time approvals to long-term compliance.
Request Your Regulatory Consulting Quote & Hourly Rates
Contact OMC Medical for a complimentary 30-minute regulatory strategy consultation.
📧 Email: info@omcmedical.com
🌐 Website: www.omcmedical.com
