"Our company had a fantastic experience with the FDA Group, and I highly recommend them. They enthusiastically assisted us in recruiting team members for several hard-to-fill roles in a very cost-effective manner as compared to what other firms charge. Equally helpful was that they thoroughly vetted candidates such that we ultimately hired 50% of all candidates they presented to us. I also sincerely appreciated their radical candor and transparency, as well as their collaborative style, which helped us to work in a highly efficient way throughout our relationship. We look forward to continuing to work with them for any future search needs."
"Asymchem Boston Corporation is developing FDA GMP-compliant small molecule API production capabilities to support pre-clinical/Phase I testing. The FDA Group was contracted to perform an assessment of the lab space, equipment, processes, and quality systems and review of data associated with a mock GMP run for compliance with FDA GMP regulations and identification of gaps.
The collaboration between Asymchem Boston and The FDA Group was organized, with clear communications of expectations, scheduling, and cost. The auditor assigned to the assessmenthad previously consulted for other Asymchem sites, and that knowledge helped with understanding the processes in place at the Asymchem Boston Site.
A draft agenda was provided for review to ensure it matched the scope of the assessment, and documents were requested for review in preparation for the assessment. A daily wrap up of items reviewed and suggestions for improvement was communicated at the end of each day, with a summary of findings and recommendations provided at the end of the assessment.
The draft report was provided for review to ensure content accuracy before issuance of the final report. Asymchem Boston Corporation really appreciates the time, efforts and knowledge provided by The FDA Group for the assessment of FDA GMP readiness. The report and responses will be used to demonstrate Asymchem Boston Corporation's compliance with FDA GMP regulations as they apply to pre-clinical/Phase I processes. Thank you very much!"
“I’ve had the pleasure of working with The FDA Group on Quality System matters as they pertain to the FDA. The FDA Group was brought in to perform a thorough gap analysis in several areas of our quality system, to suggest mitigations for these gaps, and to help with Quality System training to ensure that the proposed mitigations were properly understood and implemented. I found The FDA Group to be particularly well-matched for the needs of our small operation, as they took pains to thoroughly understand the details of our existing processes and to reshape these in a way that satisfied the necessary requirements while minimizing the impact to the existing workflow. Their intimate familiarity with the many requirements made our exchanges efficient, as they could quickly steer the discussions towards providing effective solutions without pausing to research the details of the regulations. Their experience as a trainer/teacher for lead auditors facilitated our discussions, as they presented information in a clear and uncomplicated way, often supporting it with varieties of the materials and practical examples."
“I highly recommend contacting The FDA Group, LLC if your company is in need of regulatory consulting. They have successfully matched the right consultant to the right issue for our business many times. From day-to-day Regulatory Affairs questions and training to significant issues such as recall management and 483 responses, The FDA Group has a pool of consultants to pull from that can assist you both expeditiously and professionally.”
“To all who are considering doing business with The FDA Group, we would recommend them with no hesitation. The FDA Group is very professional and does business promptly. They responded to us at all hours of the day or night if we were trying to resolve a situation and move ahead. We know you will be satisfied with the project done for you.”
“I am happy to inform you that this case has now settled. I believe that your contribution and expertise helped to convince the defense that settlement would be the most appropriate means of resolving this matter. I appreciate all the work, effort and guidance that you have given me in this case. Again, I enjoyed working with you.”
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