Startups often have limited budgets. A consultant helps you meet compliance requirements without a full-time salary, benefits, and overhead.
Startups usually lack in-house regulatory knowledge. A consultant brings years of experience without the need for training.
You may only need regulatory and quality support for FDA submissions, ISO certifications, or supplier audits rather than ongoing daily work.
A consultant can streamline regulatory approvals (FDA 510(k), CE Mark, ISO 13485), avoiding costly delays.
You stay informed at every step with clear deliverables, progress updates, and open communication.
Hiring a full-time employee too early can be risky if you’re unsure of long-term needs.
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!
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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:
Great for gap assessments, audit prep, supplier qualification, or remediation efforts.
If new FDA/ISO regulations come into play, a consultant can help update your QMS without hiring permanent staff.
If facing an FDA warning letter, recall, or CAPA backlog, a consultant provides expertise without disrupting operations.
If your quality/regulatory needs fluctuate, hiring a consultant avoids the cost of maintaining a full-time team.
Consultants bring fresh, objective insights that internal teams may overlook.
25+ Years of Regulatory Experience
| Company Stage | Recommendation |
|---|---|
| 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 needs, a full-time employee might make sense. |