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AccuReg provides a full range of consulting and
technical services to the pharmaceutical, medical
device and diagnostics and over-the-counter (OTC)
industries. Our participation ranges from guidance
and advice, to on site collaboration and training,
to turnkey delivery. Our primary service areas are:
- Quality Systems, Compliance and Engineering
- Audits
- Software Services
- Clinical Services
- FDA Submissions
For pharmaceutical, medical
device and OTC companies, AccuReg offers guidance
and “hands on” support in the following critical
compliance areas:
- Quality Systems and compliance development and
implementation (including comprehensive Master Plans
for firms under consent decree and/or injunction)
- FDA 483 and Warning Letter responses and action
plans
- Comprehensive documentation and record-keeping
systems
- Development and review of individual compliance
documents, including Master Batch Records (MBRs),
Device Master Records (DMRs), Device History Records
(DHRs), Device History Files (DHFs), Standard
Operating Procedures (SOPs), Standard Test
Procedures (STPs)
- Development and implementation of complaint
handling systems
- Development and implementation of Corrective and
Preventive Action (CAPA) systems
- Design control process development, implementation
and training
- Business process re-engineering (BPR)
- Package design
- Process automation and control
- Process analysis/methods improvement
- Method and process validations
- Software and computer systems validations
- Production equipment procurement
- Product equipment relocation
- IQ/OQ/PQ of equipment and systems
- Development and implementation of Validation
Master Plans and validation SOPs
- QS Regulation, GMP, GLP and GCP training programs
for personnel at all levels
- Internal Audit and clinical audit training.
Audits are an essential quality tool for verifying compliance, good practices and progress. In addition, they are often the first step to developing an action plan in areas where “opportunities for improvement” are already known to exist.
AccuReg’s standard practice is to conduct each audit with an eye to solutions. Our audits are as broad and deep as the situation warrants and your priorities dictate. After the inspection is complete, we generate a detailed written report or high-level written summary documenting our observations. Again, the scope of the report is dependent on your goals for the audit and the format that best serves those goals. All audit reports include recommendations to resolve identified issues. At your request, we can also help you prioritize the action items, develop a formal plan and work with your staff or vendor to implement the recommendations.
We Offer:
- Comprehensive vendor, facility and documentation quality audits
- Bioequivalence / Generic drug audits
- Independent QS Regulation and Good Manufacturing Practice (GMP) audits
- Good Laboratory Practice (GLP) audits
- Simulated pre-approval inspections
- Clinical study, clinical site, and SMO/CRO audits for compliance to protocol and GCPs
- Combined QS Regulation / ISO 9000 Pre-Certification audits
- Design control audits
- Software quality audits
- Electronic Records/Electronic Signatures (21 CFR Part 11) compliance audits and actions plans
- Internal audit and clinical audit training
Our software services are designed to support the compliance of medical-device software and systems, Quality System software and systems, clinical data management and analysis software and systems, product testing and manufacturing systems, and electronic records/electronic signatures systems. We are experienced in the successful development and filing of regulatory submissions for a variety of software medical products ranging from a Low to High Level of Concern, and have worked extensively with many proprietary and commercial software products to develop sound validation plans and design control processes.
Our software services include:
- Gap analyses of existing software and computer systems
- Software quality audits and design control audits
- Software and computer systems validation (ranging from turnkey solutions to supplemental, hands-on support, to project management and oversight)
- Software Quality Assurance support
- 21 CFR Part 11 audits and solutions implementation
- Commercial software and vendor qualification audits
- Development and review of verification and validation programs and procedures
- Development of Master Validation Plans (MVPs)
- Design control process and procedure development, implementation and training
- Software and documentation change control processes and procedures
- Traceability processes and matrices
- Software and computers systems risk management processes and procedures
- Retrospective validation of legacy systems
- Validation of SAS-based data management and analysis systems
- IQ/OQ/PQ of equipment and system components
AccuReg’s clinical services focus on identifying and preventing or correcting problems before issues impact the quality, integrity or duration of the study. PharmDs, PhDs and other medical and regulatory professionals staff our clinical division. They possess extensive practical experience in industry and academia.
Note: AccuReg is not a CRO or SMO, and does perform routine clinical monitoring. Our Clinical division is an auditing, design review and Quality Assurance resource that also supports client regulatory submissions and reporting.
Our clinical auditing services include:
- Assessments of protocol compliance, including evaluation of subject selection, conformance with inclusion/exclusion criteria, informed consent, concomitant treatment information, post-treatment evaluations, surgical procedures and laboratory assessments
- Data verification and evaluation for integrity and validity, identification of inconsistencies and anomalies
- Examination of documentation practices, including CRFs, source records, and test article accountability
- Identification of study-specific concerns, including adverse event recording and ADR reporting
- Evaluation of clinical site acceptability
- Evaluations of IRB conduct and, if applicable, SMO/CRO performance
- Preparation of Clinical Risk/Benefit Analyses, risk assessment documents, and regulatory reports
Other clinical services include:
- Protocol development and review
- Statistical analysis and review
- Data management process development and review
- Case Report Form (CRF) development
- Clinical procedures development
- Training in procedures and Good Clinical Practices (GCPs)
- Pre-IND/IDE meetings
- Preparation of, coaching and participation in Advisory Committee Meeting presentations
- Investigator Meeting coordination and participation
- IRB selection and review
- Clinical site selection and review
AccuReg is experienced in the preparation, critical review, assembly and filing of the following regulatory submissions for pharmaceutical and medical device products:
- Investigational Device Exemptions (IDEs)
- Pre-market Notification [510(k)] Applications
- Pre-market Approval Applications (PMAs)
- Investigational New Drug Applications (INDs)
- Traditional and Abbreviated New Drug Applications (NDAs/ANDAs)
- Chemistry, Manufacturing and Controls (CMC) Sections
- 505(b)(2) Applications (aka “Paper NDA”)
- Drug, Device and Biologic Master Files – Domestic and Foreign
- Certifications for Consent Decree Remediations, Bioequivalence, etc.
Our Associates can work with your team to coordinate development of entire submissions, prepare turnkey inclusions (e.g., technical/manufacturing sections, software sections, clinical data analyses, validation reports, literature summaries, etc.), or any combination of participatory services.
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