About us
We’re more than just regulatory/quality advisors
Premier Regulatory Consultants are ex-FDA Investigators who have over 20 years of experience conducting GMP, GCP, GVP & GLP inspections regarding drugs, medical devices, biological products and food.
We understand that there are multiple factors that should be considered when developing medical products. That’s why we offer fully customised solutions to suit your unique situation, which reflect the current regulatory environment.
Why choose us?
Expertise
We have the expertise to navigate this ever changing industry.
Passion
We are passionate about the work that we do because it impacts patients lives.
Quality
We ensure that quality is built into our services from begining to end.
Personal approach
Our approach will be tailored to your specific needs.
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Highly qualified advisers across all sectors
Premier Regulatory Consulting is passionate about enhancing organizations regulatory and compliance infrastructure to improve heath outcomes for all.
Training services
- Host Workshops & Webinars.
- Develop & Facilitate Trainings.
- Virtual Services.
- Regulatory Coaching for Clinical Investigators
Writing services
- Enhance SOPs.
- Response to 483 and Warning Letters.
- Responses to Recalls & Corrections.
Regulatory services
- Inspection Readiness
- Audit Support.
- Crisis Intervention for 483 and Warning Letters
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