Beaufort Solution: Beaufort helped the company resolve ASR compliance issues with the pre-IDE submission and crafted an appropriate pre-IDE submission and project plan. Prior to mediating the pre-IDE meeting with the FDA, Beaufort helped the company develop a presentation and assisted with a dress rehearsal.
Beaufort Solution: After identifying pathways to a Class II device classification, Beaufort prepared a strategic regulatory plan for the test kit, enabling the company to satisfy regulatory requirements in a cost-effective manner. Beaufort drafted a pre-IDE filing, including a clinical trial plan, and provided coaching to the client as it prepared for its pre-IDE meeting with the FDA. After successful meetings with FDA officials, the company relies on Beaufort for continued support as necessary, including assisting with preclinical and clinical trial activities.
Beaufort Solution: These actions included a review and revision of its Quality Document System, a review of its Computer System Validation (CSV) Plan, and performing Vendor Audit Assessments. Beaufort performed an in-depth review of the company’s current document system, including meetings with all key stakeholders. This review led us to suggest several alternative document structures. The final project deliverables included an SOP Assessment Report, complete Document Index, revised SOPs, Flow Diagrams, Glossary of Terms and Definitions and an SOP Writing Style Guide.
Beaufort Solution: Beaufort conducted these audits on behalf of the company, which allowed the company to make informed decisions as a clinical trial sponsor. This client has since requested Beaufort’s additional support in developing a Quality System and assisting with its 510(k) submissions.
Beaufort Solution: The client sought assurance that clinical data was valid and could support a PMA submission. Lacking sufficient internal resources, the client selected Beaufort to conduct the assessments. Beaufort planned and audited two clinical sites and worked with the client to gain historical information regarding site staff and data collection. Beaufort recommended performing an audit of the sponsor’s trial master file prior to auditing clinical sites, thus ensuring that the sponsor held required regulatory documents for each site. Beaufort provided audit reports and held subsequent discussions with the client, enabling it to make informed decisions regarding the integrity of data associated with the clinical trial. The output of these audits provided the client assurance that its required study files were in order for potential FDA inspection following the submission of the PMA.
Beaufort Solution: Realizing it had insufficient internal resources, the Quality Assurance division sought assistance in transitioning from a paper-based document system to a software-based document control system. Beaufort performed an initial review of its system to identify any existing gaps. This effort included a review of approximately 670 SOPs and 350 forms for content including obsolete references; document relevance; assignment of appropriate ownership/responsibility; and potential for SOP deletion, modification, or combination. In addition, Beaufort worked closely with functional areas to gain an understanding of the numerous processes and how they were potentially linked. This assignment led to a follow-on SOP project.
Beaufort Solution: The company’s products range from early detection and prevention of diseases to diagnosis, treatment and treatment monitoring, and this was the first time it had turned to outside resources to fill its needs. Beaufort developed a turnkey clinical trial management plan, beginning with site identification/qualification and essential document development for three separate clinical trials. In parallel, Beaufort performed a formal Risk Analysis Plan to ensure the project team was aware of the potential risks involved in performing three clinical trials within the very short time frame required by the client. The plan identified potential risks, mitigating factors and planned corrective actions if identified risks occurred. Beaufort initiated site identifications/qualifications and prepared the project operations.
Beaufort Solution: The company needed a clear regulatory strategy for bringing its project to market in the shortest possible time frame. In addition, the client needed clinical trial management and data entry to support a 510(k) submission to the FDA. Beaufort provided ongoing regulatory consultation and conducted the clinical trials, including site identification/qualification, clinical study and regulatory document preparation, IRB submissions, site monitoring and data entry in support of the company’s first 510(k) submission to the FDA.
Beaufort Solution: Beaufort provided clinical trial management support, including clinical trial and regulatory document preparation, IRB submissions, and clinical trial monitoring support. This support enabled the company to make its first successful 510(k) submission to FDA.
Beaufort Solution: The company’s previous interactions with FDA highlighted a need for assistance in finalizing its clinical trial protocol, subsequent clinical trial management, and preparing for a pre-IDE meeting with FDA. Beaufort developed a comprehensive clinical trial protocol that provided the statistical power to support the intended uses. Beaufort prepared the company for interactions with FDA and meetings with the agency. Following these meetings, FDA supported the clinical plan which enabled the trials to move ahead and Beaufort located, qualified, and coordinated clinical trial sites for a highly time-sensitive trial.
Beaufort Solution: Maintaining frequent contact with the client to stay abreast of ever-changing needs, Beaufort presents pre-screened and highly qualified candidates to the client’s management. This arrangement gives the client the ability to move forward with its field monitoring, knowing that its CRA pool can be supplemented with Beaufort field monitors across a wide spectrum of therapeutic areas and geographic locations. Beaufort’s flexibility, knowledge of monitoring practices, and our ability to deliver qualified CRAs in specific regions of the country has enhanced the client’s monitoring program and reduced travel costs.
Beaufort Solution: This was this division’s first use of an outside vendor to manage clinical trials in support of an FDA submission. Working closely with the client to obtain a full understanding of its processes, Beaufort created systems to manage the trials, combining the client’s operational procedures with our suggestions for system improvements. Clinical trial management included site and investigator qualification, IRB submissions, training, and site monitoring. Beaufort served as a conduit between the sponsors and the clinical sites during the trial for communications and trouble-shooting to ensure necessary processes, documentation, and data collection were in compliance with GCPs.
Beaufort Solution: The lack of internal expertise and infrastructure threatened this client’s ability to successfully achieve its business objectives. Beaufort was initially brought in for regulatory support, but as the project progressed, the client realized it needed assistance with clinical trial management as well. Beaufort created a collaborative environment to carry out the many responsibilities with the various partners in order to achieve the necessary results, including 510(k) clearance of this client’s medical device.
Beaufort Solution: Beaufort designed an IND strategy that addressed the challenges facing an oncology vaccine, while taking into consideration the problems faced by other companies with similar compounds. Beaufort provided CMC support for the client’s manufacturing efforts. In addition, Beaufort consulted on and prepared the pre-IND package for the FDA. The client received such a clear positive response to the package that a meeting with the agency was deemed unnecessary. This process facilitated the near-term development of its compound and led the way for the international Phase II program.
Beaufort Solution: Division management had a clear plan for the scope of its product but lacked the regulatory expertise necessary to devise the most time-efficient and cost-effective approach for launching a new product. The company engaged Beaufort to develop a comprehensive regulatory strategy focusing on all aspects of the new technology, including biomarker targets and methodology. Beaufort provided a complete regulatory strategy that classified the device for the company including identification of potential predicate devices and assessed the possible pathways for the product, as well as timelines, associated tasks, and costs for each type of submission. The company is using this strategy to plan its current product development. In follow-up to the initial Regulatory Strategy for 510(k) submission, the company tasked Beaufort with providing a Regulatory Opinion. Specifically, the company provided 14 questions regarding its top priority and most controversial products due to the biomarker detection and Beaufort provided comprehensive answers to all of the questions.
Beaufort Solution: In-house clinical trial plans and previous 510(k) submissions had been rejected by the FDA. The company engaged Beaufort to redefine the intended use of the assay and provide guidance regarding effective interactions with FDA. Beaufort redefined the intended use to specify the results of the product and to enable FDA to focus on the potential positive uses of the product. After previous applications, literature, and data were reviewed, Beaufort redesigned a clinical trial protocol that would support the new intended use of the assay, providing appropriate focus on the actual functionality of the product. This done, the client was positioned to move forward in their plans for the product.
Beaufort Solution: The company wanted a comprehensive regulatory perspective encompassing the various potential pathways for converting ASRs into diagnostic kits, as well as assistance in creating the pre-IDE information packages for each product. Working with the company’s internal resources, Beaufort completed this assignment, and, in addition, reviewed relevant literature and created a pre-IDE information package which included a high level clinical trial protocol for FDA review.
Beaufort Solution: Before engaging Beaufort, the company had been advised that it would be unable to register a major product in the United States. Beaufort worked with senior management to consider regulatory alternatives including a switch to cGMP-compliant manufacturing. As a part of the process, Beaufort provided a thorough review of all documents related to the company’s products, inspected its plant and other operations, and trained employees regarding regulatory process and criteria for submissions. As a result, the client passed a Health Canada regulatory inspection, won approval for its product in Canada, and is on the road to full cGMP compliance with an IND pending with FDA.
Beaufort Solution: Founded by an academic physician, a chemist, and a business person, the company had a clear vision regarding its business objectives but lacked the expertise necessary to navigate the FDA regulatory maze. As a result, its initial in-house orphan disease application was rejected by FDA. Realizing its need for experienced guidance, the company engaged Beaufort to develop a comprehensive regulatory strategy taking the compound’s history into consideration. Beaufort prepared a new orphan drug application, which was cleared in one review cycle. Beaufort also provided ready-to-use information for investor and academic presentations. Since engaging Beaufort, the company has increased fundraising, cleared an additional orphan drug application, and is proceeding with a sound regulatory strategy.
Beaufort Solution: Beaufort addressed numerous gaps with the client’s design control system to establish root causes, corrective and preventive action (CAPA) plans, and effectiveness verification checks. Specific gap-closure activities included procedure generation, training, Design History File (DHF) creation, and records review related to all aspects of design controls. Work involved interfacing with and engaging numerous site personnel having limited knowledge of regulatory regulations. The project was further challenged with aggressive business priorities that competed with the same personnel and involved multiple sites. Beaufort was instrumental in closing these gaps through a unique blend of hands-on involvement, training through mentoring, and great flexibility. Our collaboration and work with this client ensured it was capable of meeting regulatory and corporate requirements without impacting business objectives.
Beaufort Solution: Beaufort’s QA team conducted an analysis of all the possible chemical interactions of all the components of the client nine different formulations and developed a cross-contamination matrix. Concurrently, all possible equipment configurations were classified by total product contact surface area. Working directly with our client’s corporate R&D and QA teams and their manufacturing site team, we facilitated cross-functional failure mode and effect analysis (FMEA) workshops and analysis efforts to identify worst cases based on risk. We also developed the new Cleaning Validation Strategy, created all the engineering studies and validation protocols, and identified improvements using statistically sound sampling plans, visual and readily available work instructions, and hands-on training of all personnel involved with the cleaning process. As a result, our client has a fully developed strategy and executable master plan to validate an efficient, better performing cleaning process with all the documented evidence to prove it.
Beaufort Solution: The acquired global business unit had a validation process that was different and did not meet the global validation requirements of the parent corporation. We performed a “deep dive” assessment of its validation process: from the technical and compliance assessment of the original validations, through its current process and approach, to the gap analysis for implementing a new validation process that met all the requirements of the new parent corporation.
The assessment confirmed that there was an opportunity to create a competitive advantage by minimizing compliance risks and improving operational performance of the new business unit by the implementation of a new validation process designed according to the latest industry standards that meets all requirements of the parent corporation. The Beaufort QA team, working side by side with its validation, quality, and engineering teams, developed the new Validation Master Plan, updated all of the documentation, facilitated the required training, and identified all the implementation mechanisms for ensuring a successful integration of the new validation system and the execution of the required re-validations at the newly acquired business unit.
Beaufort Solution: The Beaufort QA team conducted a comprehensive technical assessment and applied the DMAIC methodology and five Whys in order to perform and document a comprehensive root cause exercise. Concurrently, a statistical analysis was conducted on all available historical and current year performance data and we were able to determine that the system was performing as designed and in a “state of control” against our client’s process specifications. Then a process failure mode & effect analysis (FMEA) was executed in order to evaluate each risk and provide a solid base for solution development and prioritization.
Based on the information developed and working directly our client’s team (operators, lab technicians, maintenance mechanics, QA personnel, and process engineers) and the support team from its purified water system technical supplier, we designed an overall solution that addressed all of the critical/high risk technical deficiencies identified in the FMEA stage and then developed a re-validation/implementation plan that will be executed during the plant’s next maintenance shutdown. As the project progressed, all deficiencies that required immediate attention were submitted to change control and properly resolved, and a software validation master plan for the control system was developed with all its diagnostics/statistical tools fully functional. The overall project did not only provide our client with a fully compliant purified water system but it has the potential to generate significant operational savings after implementation.
Beaufort Solution: Beaufort assisted the client in formulating a new strategy that would support the validation of a new e-beam sterilization process while meeting upcoming requirements of future products with improved service levels and reduced cost requirements. We then facilitated the selection of a new sterilization services supplier who could meet the cost and service level requirements and assisted the client with the certification the new approved supplier. As a result of the project, the client is able to accommodate significant new growth within its existing footprint and reduced the complexity of its supply chain using a highly efficient sterilization process at a significant cost savings and also improved their cycle time and customer service levels.
Beaufort Solution: The acquired global business unit had recently implemented an ERP system that was different and did not meet the global system requirements of the parent corporation. Our evaluation considered the current and projected use of the global ERP system, the underlying business drivers for it, the implementation time frames and ability of the acquired unit to meet the new corporate software requirements. Our assessment confirmed that there was superior value in improving and re-validating the business unit’s ERP system and identified mechanisms for ensuring that re-validation and integration was fully compliant and met all the software requirements of the parent corporation.
Beaufort assembled a software validation and implementation team that not only worked with the IT team of the newly acquired business at its HQ office, but had sub-teams deployed at each strategic global location. By taking this approach, we were able to provide our client a global best solution that addressed all of the corporate and integration requirements at the HQ office and took into consideration all the operation needs at each site. Our team was able to improve, integrate, and revalidate a global ERP system that met all the requirements of the new parent corporation within schedule and below budgetary guidelines.
Beaufort Solution: While the new system promised to help automate packaging inspection and final product disposition, our client was concerned that the technical limitations of the existing equipment on each packaging line and its engineering team expertise were not efficient enough and unable to fully capitalize on the capabilities of the new system. We facilitated cross-functional (packaging materials supplier, validation technician, quality technician, process engineer, and maintenance staff) team meetings and ongoing design and testing analysis reviews covering the critical performance qualities of an automated inspection process to identify deficiencies with the current equipment and process, and developed all the engineering studies and validation protocols.
As the project progressed, our team also identified several process improvement opportunities to lower cost, reduce cycle time and enhance the quality of the client’s packaging process. The validation plan was rapidly adjusted to incorporate these improvements into the validation protocols and training regimen. As a result, once the technical upgrades on each packaging line and the specialized training are completed, our client has a fully developed and executable plan to validate an efficient, better performing packaging process that was standardized and optimized to take full advantage of the capabilities of its new vision and optical recognition system.
Beaufort Solution: A majority of the company’s clinical and regulatory staff had never participated in a regulatory inspection and anxiety levels were running high. Beaufort began the project by interviewing all pertinent personnel to establish its experience level and determine the company’s preparedness for the inspections. Our work included extensive document reviews, mock audits, extensive training sessions, both seminar and one-on-one. Beaufort also developed white papers to share with regulatory authorities during the inspections. We developed a series of mock inspections and follow-up activities, and the client passed all regulatory inspections with minimal audit findings, including a major FDA pharmocovigilance inspection.
Beaufort Solution: The company’s product had demonstrated significant promise based on animal and theoretical models. However, it needed guidance in getting to the first stage of the IND/IDE process. The company engaged Beaufort to support this development. Beaufort worked with management to assess existing and potential competitive products and to determine which of the potential indications should prove most valuable. Our work included a regulatory strategy for optimally approaching the IND/IDE stage of product development with the result that the client now has a detailed plan with a streamlined set of possible indications.