Fractional Resource

Do you have questions for Quality and Regulatory from time to time but don’t need a full-time resource? There is often a misconception that hiring a consultant will cost more than a full-time employee – WRONG!

Hiring a part-time quality and regulatory consultant instead of a full-time employee offers several advantages, especially for medical device companies, biotech firms, and startups. Here are the key benefits:

1. Cost Savings
   – Lower Overhead: No need to pay for full-time salary, benefits, or bonuses.
   – No Long-Term Commitment: You only pay for what you need, reducing financial burden.
   – Avoid Hiring Costs: No need for recruitment expenses, onboarding, or training.
2. Expertise on Demand
   – Access to Specialized Knowledge: Consultants bring extensive experience from multiple companies and industries.
   – Regulatory Expertise: They stay updated on FDA, ISO, and other regulations so you don’t have to.
   – Faster Problem Solving: A seasoned consultant can quickly assess and fix compliance issues.
3. Flexibility & Scalability
   – On-Demand Support: Scale up or down as needed (e.g., during audits, submissions, or product launches).
   – Short-Term Commitment: Use them only for critical projects like FDA submissions, ISO audits, or CAPA resolutions.
4. Reduced Business Risk
   – Audit Readiness: A consultant ensures compliance without the risk of hiring the wrong full-time employee.
   – Objective Perspective: They provide unbiased recommendations to improve quality systems.
   – Avoid Turnover Issues: No risk of losing key personnel, which can disrupt operations.
5. Faster Results
   – Immediate Impact: No need for long training or ramp-up time.
   – Efficient Execution: Experienced consultants work faster and more effectively than many full-time hires.
   – Regulatory Submissions & Certifications: A consultant can accelerate product approvals, reducing time-to-market.

Here’s a tailored comparison of hiring a part-time quality and regulatory consultant vs. a full-time employee, depending on whether you’re a startup or an established company:

For a Startup (Early-Stage or Scaling)

Why a Part-Time Consultant is Better:

✅ Cost-Effective: Startups often have limited budgets. A consultant helps you meet compliance requirements without a full-time salary, benefits, and overhead.

✅ Regulatory & Quality Expertise: Startups usually lack in-house regulatory knowledge. A consultant brings years of experience without the need for training.


✅ Flexibility: You may only need regulatory and quality support for FDA submissions, ISO certifications, or supplier audits rather than ongoing daily work.


✅ Faster Market Entry: A consultant can streamline regulatory approvals (FDA 510(k), CE Mark, ISO 13485), avoiding costly delays.

✅ Risk Reduction: Hiring a full-time employee too early can be risky if you’re unsure of long-term needs.

When a Full-Time Employee Might Be Needed:

❌ If you have a complex product that requires daily regulatory oversight.

❌ If you’re scaling rapidly and expect continuous quality system management.

For an Established Company

Why a Part-Time Consultant is Useful:

✅ Project-Based Work: Great for gap assessments, audit prep, supplier qualification, or remediation efforts.

✅ Regulatory Changes & Compliance: If new FDA/ISO regulations come into play, a consultant can help update your QMS without hiring permanent staff.
✅ Crisis Management: If facing an FDA warning letter, recall, or CAPA backlog, a consultant provides expertise without disrupting operations.

✅ Cost Savings: If your quality/regulatory needs fluctuate, hiring a consultant avoids the cost of maintaining a full-time team.

✅ External Perspective: Consultants bring fresh, objective insights that internal teams may overlook.

When a Full-Time Employee Might Be Needed:

❌ If you have ongoing compliance needs and a high volume of regulatory submissions.

❌ If your company is large enough that maintaining a dedicated Quality & Regulatory team is more efficient.

Final Takeaway

• Startups benefit most from consultants because they save money and provide expertise on demand.
• Established companies can use consultants for specific projects but may need full-time employees for ongoing quality management.

Would you like help determining which approach fits your specific business needs?

To determine whether a part-time consultant or a full-time employee is the best fit for your business, here are a few key questions:

What stage is your company in?

• Startup / Early-Stage → A consultant is usually the better choice.
• Scaling / Growth-Stage → A consultant can help temporarily, but a full-time hire may be needed soon.
• Established Company → If you have ongoing compliance work, a full-time employee might make sense.

How frequent are your quality and regulatory needs?

• Occasional (FDA submissions, audits, certifications, supplier issues, etc.) → Consultant.
• Regular (ongoing QMS management, CAPA tracking, regulatory updates, etc.) → Full-time employee.

What is your budget?

• Limited budget / Need flexibility → Consultant.
• Able to afford salary + benefits → Full-time employee.

Are you preparing for an audit, submission, or specific compliance project?

• Yes → A consultant can help get you through these milestones efficiently.
• No, we need long-term quality oversight → Consider hiring full-time.

Do you already have in-house expertise?

• No, we need expert guidance but can’t afford full-time → Consultant.
• Yes, but we need additional ongoing support → Full-time employee.

So, what can Simplimedica do for you?

If you’re in the early stages, working on specific regulatory milestones, or need flexibility, a part-time consultant from Simplimedica on demand is what you need.

Get in touch for a FREE 30 min call with Adnan Ashfaq on how I can help you!

Package	Days of C.O.D.	Budget Needs	Estimated Cost for Retainer	Estimated Cost for Employee	When this Service will be best for you
Bronze	1 day per month (you can use this in minimum 1 hour meeting slots)	12 days annual access to Adnan Ashfaq	Get in touch for a quote	£82,000 plus benefits	Minimum Quality and Regulatory requirement for Start-Up to have a PRRC or Quality professional on the books (limited to review and consultation)
Silver	1 day per week	48 days annual access to Adan Ashfaq	Get in touch for a quote	£82,000 plus benefits	When having more regular requirement and input is needed in Design, Development and also perhaps in creating documentation
Gold	Fixed budget retainer	You have a specific budget released for QARA work	Get in touch for a quote	£82,000 plus benefits	You have a specific budget released for QARA work that needs an Interim QARA person to also create documents not limited to review