What should you be thinking about before your regulatory submission?
In short – are you truly ready for your final regulatory submission? And if not, how are you planning to get there?
The best answer is to work with a team of Quality Assurance professionals who have been there and done that. People, for instance, who have decades of clinical development experience — covering everything from the FDA, EMA, MHRA and BfARM to DEA, ANSM — and have successfully managed 10 regulatory inspections which resulted in product approvals.
At Aperio, our Quality Assurance Services team is uniquely positioned to help you understand the big picture — and take care of all the details that can make the difference between success and failure.
We’ll tailor our engagement to support and supplement your team. We’ll show you the cumulative benefits of implementing a step-by-step inspection readiness plan. We’ll create a customized plan that’s specific to your indication and findings. And we’ll call out weak arguments and incomplete data. All to make sure that you’re more than ready when the agency arrives or at any point in the process.
Our Quality Assurance Services team can guide you every step of the way.
- TMF Audit
- Clinical Site Inspection Readiness Visits
- BIMO or other applicable questionnaire
- Inspection Readiness Training
- Mock Inspection
- Host or Co-Host Inspection
- Management of your Inspection Readiness Room
Or we can take you through just the specific steps you need, including:
- Site Audit
- TMF Audit
- Vendor Audit
- Quality Document Creation
It was refreshing during this audit to work with a QA person that is so operations based and understands what the objectives of running a trial using documented processes versus a QA auditor that is higher level and is more concerned with checking boxes than ensuring the processes and procedures are solid.
In my opinion, the work Aperio did in preparing the sites and attending the inspection really made the difference in the positive result we obtained and this opinion is shared by the key site personnel.
The Aperio QA team members were extremely professional and knowledgeable and provided ample feedback which will enable continued growth in our organization. Because of the high caliber of these individuals, our senior management teams remained engaged the entire time and are working on remediating some of the noted deficiencies on our end. I would not hesitate to obtain additional services from Aperio in the future due to the impressive quality of these individuals.
I’m always impressed with the quality and performance level and caliber of the Aperio team-members. I so appreciated the Monday dry run and the opportunity to have observers in each of the room throughout the mock. Your direct, real-time critique with suggestions and overall performance assessment has already proven invaluable to our quality department and the wider organization. I look forward to our continued partnership and collaborative efforts to ensure we achieve a constant state of inspection-readiness.
We had an excellent experience with the Aperio QA team, they really provided excellent insight and knowledge to help better prepare us for an actual inspection from a health authority. They were professional, knowledgeable, prepared and collaborative. They all provided quality feedback which added significant value to our experience in preparing for an actual inspection.
MEET THE EXPERT
Tony Bumarch, VP Global Quality Assurance, has over 25 years of quality assurance experience. Prior to joining Aperio, Tony was the Director Global Quality Assurance at Teva and has been part of over 10 agency inspections for regulatory submissions. His QA experience spans across various agencies including FDA, EMA, MHRA, BIARM, DEA and GCP. Tony is astute with mock inspections, interim and final TMF audits, clinical site audits, BIMO questionnaires, and vendor and agency audits. His emphasis is on organizational inspection-readiness – or, “begin with the end in mind”.