Quality, Compliance & Regulatory Services
Med Reps delivers Quality, Compliance, and Regulatory Services to Life Sciences companies.
When partnering with Maetrics, our clients gain the advantage of our commitment to delivering regulatory compliance solutions that will provide a foundation of integrity, productivity, and quality for years to come. Our collective depth of skills enables us to provide a full range of consulting services, all of which are customized to individual needs and allow clients to be recognized in their industry for their focus on quality.
Business Development Services
Med Reps™ strategies provide a plan of action for life sciences companies to assist in managing regulatory challenges and consistently achieve acceptable standards of compliance.
Regulatory compliance requirements extend throughout the full product lifecycle beginning with the first specification draft, development through approval, manufacturing, launch, and required post market reporting. Neglecting industry regulations can lead to significant setbacks in trying to achieve your strategic objectives.
Med Reps™ offers the insight needed to guide regulatory strategy across the pharmaceutical, biotech, medical device, and diagnostics industries.
Comprehensive & Actionable Guidance for Life Sciences Organizations is achieved by identifying regulatory issues then developing and executing customized plans that position your organization for success. We assess company operations, pinpoint areas requiring adjustment, and then put solutions in action. Whether you are planning a new submission, managing new regulations, or conducting a readiness assessment, Med Reps™ will leverage our broad knowledge of life sciences manufacturing and operational processes to devise an effective strategy.
Med Reps™ offers a broad level of support to include
- 510K submissions
- IND/NDA Submissions
- IDE/PMA Applications
- Authoring, compiling, and remediating technical files and design dossiers
- Development and creation of Clinical Evaluations Reporting
- Full remediation strategy and implementation
Med Reps™ will lead your organization to sustainable compliance success and help lay the groundwork for performance and innovation.
Quality Management Systems.
Med Reps™ Quality Management Services will not only diagnose nonconformities but also assist clients with practical solutions, providing a path toward controlling and monitoring operations.
As a component of regulatory standards, quality management requires a system for controlling, monitoring, and verifying any activity or process that could affect product conformance.
Med Reps™ works collaboratively with clients to guide quality management strategies. We possess the experience to devise customized solutions to specific quality management issues. We also construct both local and company-wide strategies for meeting regulations within the biotech, pharmaceutical, diagnostic, and medical device fields.
Quality Management Expertise and Customized Training provided by Med Reps covers the full range of quality systems initiatives
- Internal process and quality system audits/assessments
- Pre-certification audits
- Document control
- Design control
- Manufacturing and production processes
- Standard Operating Procedure (SOP) development
- Supplier quality and purchasing controls
- Labeling consistency and accuracy
- Complaints, Corrective Action/Preventive Action (CAPA), Adverse Event (AE), and Medical Device Report (MDR) processes and systems
Med Reps™ also provides customized training based on an organization’s requirements, to ensure teams are utilizing the current best practices. We offer instruction on areas such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Quality System Regulations, ISO 13485 & 14971, Medical Device Directives (MDDs), auditing, validation, specific regulations, and related quality management topics.
At Med Reps™, we design our programs to meet your specific needs which includes the delivery of training. We offer a wide range of training platforms from on-site training to e-learning.
Ensuring that pharmaceutical, biotechnology products and medical devices meet a high level of quality is paramount to the success of your organization. Each member of an organization, from executives to resource suppliers, plays a role in how quality is factored into a company’s operations, and Med Reps™ can help guide your company to making quality a duplicable and ongoing standard.
Mitigating risk requires being aware of the potential threats and formulating the right strategy. With decades of experience, Med Reps™ provides effective solutions for proactively managing risks within the quality discipline.
Med Reps™ provides strategies that allow organizations to manage risks in a practical, effective, and proactive manner within the fields of pharmaceuticals, biotechnology, medical devices or diagnostics.
Improving Overall Performance
Med Reps™ utilizes risk management strategies as an inherent, vital part of product life cycles, supply-chain operations and quality management systems with the end goal of patient safety. Recognizing and mitigating risks early will ensure that specific activities operate according to plan and are proven to be effective.
Whether focusing on compliance, security or a variety of other issues, we develop risk plans along with a customized strategy for the following procedures:
Identifying Levels of Risk by assessing quality operations and determine the probability of occurrences that may cause harm to people, property and environment.
Develop and Implement Strategies by creating a comprehensive risk profile followed by the development of an effective and sustainable solution resulting in appropriate risk mitigation.
Monitoring and Reporting the effectiveness of the strategy and provide reports on progress and potential adjustments.
Risk management, compliance, and quality monitoring are deeply interconnected within the life sciences industry. By partnering with Med Reps™, clients will meet their risk management regulatory requirements, stay up-to-date on potential hazards, and make data-driven decisions to improve risk avoidance and mitigation, all while achieving business goals and preparing for future growth.
As the launching pad for life sciences innovations, laboratories are subject to a wide array of regulations. Med Reps™ delivers Compliance Solutions that maintain consistency, quality, and safety for our lab partners.
Laboratory operations are at the heart of the life sciences industry. In order for the latest pharmaceuticals and medical devices to reach the people who need them, the methodologies, processes, and equipment behind them must adhere to a range of quality, regulatory, and compliance standards.
Med Reps™ expertise in life sciences compliance provides the guidance needed to meet the latest laboratory requirements at all levels. Our assessments of processes and equipment will establish a foundation for quality and safety while helping enterprises achieve business goals.
Effective Lab Compliance Strategies
Med Reps™’ compliance leadership will ensure that engineering processes meet appropriate standards from beginning to end, regardless of product type. Our services include validation and risk management along with solutions in the following areas:
- Audits and assessments of laboratory processes and equipment
- Test method development
- Analytical assay development assistance and assessment
- Laboratory Information Management System (LIMS) quality assurance
- Cleaning processes and clean rooms
- Accreditations, licensures, and certification
By partnering with Med Reps™, life science enterprises can focus on day-to-day responsibilities while we handle quality, regulatory, and compliance challenges. As dedicated life sciences consultants, our lab services team will pinpoint compliance vulnerabilities and execute a cost-effective strategy for making performance improvements a working reality.
Med Reps™ offers a variety of education programs ranging from compliance training to sales and product training.
Providing Compliance Knowledge
Across the life sciences industry, maintaining compliance is not static due to constantly changing standards and regulations.
Med Reps™ training provides instruction needed to fully understand regulations and how they are applied to daily operations. We offer in-depth interpretations of compliance regulations and how they apply to each level of an organization as well as its service providers.
Training programs are customizable to meet specific needs by focusing on the most relevant compliance issues, presented in a platform best suited for you logistically. We offer training courses for overcoming the latest compliance challenges, as well as customized courses tailored to meet your specific needs. Med Reps™ Education sessions are held at either a Med Reps™ location or at a client’s facility, with core topics covering regulations, quality and a wide range of bioethics courses.
Sales and Product Training
Training Pharmaceutical and Sales Representatives presents unique challenges. Reps must not only be knowledgeable about the products but also on diseases, in order to engage in effective conversations with healthcare professionals.
The real challenge is in how to train these busy sales reps.
Considering the mobile nature of reps who are out selling pharmaceuticals and medical device/products, classroom training is rarely a good idea. Med Reps™ offers smart training options to quickly bring your sales people up to speed with the knowledge needed to make an effective sale.
We offer Four Training Models
- Curriculum-based Learning presents bite-sized learning modules which focus on 1-2 learning points.
- Just-in-time Learning provides a quick brush up of knowledge before meeting the physicians or other healthcare providers.
- Experiential Learning offers instructional strategies through scenarios, virtual environments, learning games, and simulations.
- Social Learning presents a secure, non-judgmental, virtual space to discuss, ask questions and offer answers to other reps.
After rolling out training, we follow up with an evaluation in order to maintain the best training programs for companies and employees.
Achieving success requires a refusal to remain static. Med Reps™ Improvement Strategies help companies gain new efficiencies while complying with regulatory requirements through a balanced and compliant system.
Staying up-to-date on changing and new regulations, the latest technologies, and the current best practices within the quality, compliance, and regulatory disciplines demands a continual process of evaluation.
Med Reps™ provides a multifaceted approach to compliance and performance improvement, offering recommendations on new strategies and methodologies. We will complete assessments to pinpoint where new tactics are necessary for enhancing quality and efficiency
New Performance Achievements
By balancing company objectives with compliance requirements, Med Reps™ delivers performance-improvement strategies. Our customized approach focuses specifically on three central areas:
- Compliance and administrative effectiveness
- Growing company revenue via adherence to regulatory requirements
- Driving efficiencies amongst all company operations to help drive margin contribution
Compliance & Administrative Effectiveness
Med Reps™ offers performance-improving strategies for strengthening your organizations approach to meeting industry standards. We devise administrative strategies that enhance your ability to locate and address compliance issues at all levels.
- Increasing compliance and quality achievements with decreased time
- Complaint handling and CAPA management
- Re-engineering QMS and business processes
- Designing quality systems’ infrastructure to better support strategy and cost
- Managing outsourcing, insourcing and service center activities within the quality, compliance and regulatory disciplines
- Designing, developing, and implementing performance management
Our quality assessments focus on manufacturing systems, equipment, and production and process controls, including software and ERP efficiencies. We deliver quantifiable results by measuring increased output, improved cycle times, improved efficiency metrics, and cost reduction.
Med Reps™ will customize strategies in the following areas:
- Ensuring operations align with business strategy
- Integrated business planning
- Achieving process standardization
- Improvement of quality and manufacturing production systems
Med Reps™ excels in delivering enterprise strategies that ensure company data is kept Secure and Compliant.
Your organization’s IT systems must provide robust storage capacity, continuous uptime, the ability to handle heavy user traffic and most importantly, high redundancy.
Within the life sciences industry, your IT system’s software and processes must meet compliance regulations under federal and international standards.
As a leading life sciences consultancy, Med Reps™ offers extensive knowledge of IT compliance requirements and the expertise to help our clients achieve that compliance.
Comprehensive IT Compliance Services
As enterprise technology becomes more sophisticated, so have compliance regulations. The cloud and software as a service (SaaS) have emerged as alternatives to traditional IT strategies, and Med Reps™ has remained in step with these ongoing developments.
Our approach involves working collaboratively with a client’s IT staff to identify opportunities for greater efficiencies and to ensure that compliance standards are met. Successful IT compliance depends on how well policies and procedures are integrated with the overall Quality Management System (QMS).
We guide clients on designing or improving their QMS, along with writing individual components, developing a compliance plan, and reviewing the overall completeness of the QMS.
IT Strategy, Architecture, & Governance
IT is not only continually undergoing new versions and updates, but is typically subject to budget constraints and changing employee needs. Med Reps™ has comprehensive experience working within the quality, compliance, and regulatory disciplines supporting finance, supply chain, research and development, customer service, and other business functions.
We possess hands-on experience covering a wide range of IT challenges:
- Strategy and Policy
- Quality Management System (QMS) procedures and methods
- Validation planning and life cycle (planning and execution of IQ/OQ/PQ)
- 510(k) device software development and testing
- Data migration validation
- Enterprise Resource Planning (ERP) software
- Laboratory Information Management Software (LIMS)
- Manufacturing Execution System (MES)
- Data collection/aggregation to support UDI/UDID
- Software Development Life Cycle (SDLC)/Software Development Methodology (SDM) testing/Software Development Process (IEC 62304)
From ensuring your digital infrastructure aligns with your business strategy to writing and executing test scripts, Med Reps™ possesses the skills and knowledge to guide IT initiatives across the life sciences industry.
Organization Change Management.
Med Reps™ provides your organization with the expertise needed to facilitate new developments and ensure compliance.
In today’s increasingly regulated environment, life sciences companies must proactively evaluate if their quality processes are evolving with industry demands.
Med Reps™ will help with pricing pressures, expanding compliance measures, advances in technology, and other operational influences that are common today.
Our approach to guiding organization change management goes beyond a strictly procedural perspective. Med Reps™ strives to understand your motivations and vision to best determine how to guide compliance efforts.
In addition to developing compliance strategies, Med Reps™ has the knowledge and resourcefulness to implement and evaluate their success.
We have a set of tools designed for customization to your industry and organization, including maturity models, status reports, key performance indicators (KPIs), and efficiency trackers.
Our Organization Change Management Procedures include:
Stakeholder management and facilitation sessions work in collaboration with key stakeholders to devise a change management strategy that establishes a culture of quality.
Capability Maturity Model Assessment provides a comprehensive assessment of current operations prior to the design of a customized solution.
Organizational realignment and HR initiatives such as new job descriptions, personnel/department restructuring, and new policy documentation.
Communication strategies guide any necessary cultural shifts while focusing on keeping employees apprised of these changes.
Training strategies guarantee employees are educated on new procedures and are able to locate all relevant resources.