MedTech

A successful regulatory strategy demands a commercial approach that targets the broadest, most-competitive product attributes and that is aligned with the development science and clinical positioning.

We work with you to confirm regulatory requirements and define the pathways to regulatory approvals and reimbursement. PharmaLex’s extensive experience with regulatory preconsultations removes the unknowns and reduces project risk.

By means of its global expertise, PharmaLex understands the importance of a well-developed strategy that targets the prime markets and then leverages initial approvals to support accelerated secondary-market access.

Even in an era of harmonization, local regulations vary widely, and we address those local differences by building comprehensive understandings of technical requirements and standards and matching them to the various regulatory processes.

PharmaLex MedTech Services helps you build a core data set in harmonized technical files to support multiple international filings.

We work with you to ensure your development processes generate technical data that meet regulators’ rigorous expectations.

Our team consists of experts in the areas of:

• Biocompatibility
• Preclinical testing
• Clinical validation
• Electrical safety
• Software validation
• Manufacturing
• Labeling and marketing
• Laboratory analysis and more

From registration application preparation, submission and management through to approval, regulatory problem solving and administrative appeals, PharmaLex MedTech works alongside you as an integral part of your team — every step of the way.

Our aim is to help you prepare complete and accurate technical files and regulatory dossiers. We specialize in risk assessments, the design history file (a US Food and Drug Administration [FDA] requirement), clinical evaluation reports and more.

PharmaLex MedTech provides global clinical development and clinical regulatory expertise to support you at every step of the clinical development pathway — from first-in-human studies through registration.

Investigational Device Exemption Applications
Our team supports companies through the entire process leading to investigational device exemption (IDEs). We support pre-IDE meetings and consolidation of submission packages for institutional review boards, ethics review boards, regulators and competent authorities throughout the world.

Good Clinical Practice Support
We provide comprehensive good clinical practice support, including investigational-site training, auditing and remediation support.

Clinical Development and Clinical Strategy Consulting
Given our expert understanding of the clinical, regulatory and competitive landscapes, PharmaLex is ideally positioned to offer smart strategies and skillful tactics for device and diagnostic-product development across the entire therapeutic spectrum. Our expert statistical analysis team provides support with designs of streamlined yet powerful statistical analysis plans.

Clinical Monitoring
Our global network provides the capabilities needed for support in the area of clinical-trials monitoring.

Clinical Program Management
We provide program management for clinical trials and act as clinical trial manager for organizations in all major regions worldwide.

Post market compliance is built on a foundation of comprehensive and continuing client-focused product feedback, monitoring and proactive regulatory reporting. Robust systems and processes are essential, and PharmaLex MedTech can help build them and train your team. In addition, we support you in the management of emerging issues with a view to minimize disruption to your business.

Our team also supports post market reporting and can serve as an outsourced reporting team or adviser. We analyze reporting trends and review reporting requirements to ensure you achieve the proper balance with a specific regulator or group or regulators in scope.

With enhanced regulatory requirements comes a heightened need for medical-writing expertise. Our team stays abreast of the latest regulatory changes as well as all related clinical evidence, including clinical-evidence reports, performance evaluation reports, literature reviews, post market surveillance reports and clinical summaries.

Leverage the experience and technical expertise of our team to generate comprehensive reports that demonstrate thorough and consistent evaluation of your product.

EU MDR Post Market Surveillance Requirements

We have a benchmarked approach to the upgrading of post market surveillance requirements to ensure you have proper clinical-evaluation-report plans, post market clinical follow-up and compliance with EUDAMED (European Database on Medical Devices).

EU IVDR Post Market Surveillance Requirements

Our team has extensive experience in transitioning previously exempt IVDs to regulated systems, upclassified IVDs, and new entrants to the European Market.

Clinical Evaluation Reports and Performance Evaluation Reports

We provide the services of authoring, reviewing and consulting to ensure your clinical evaluation reports and performance evaluation reports meet local requirements, including those of the EU MDR, Australia’s Therapeutic Goods Administration and China’s National Medical Products Administration. We offer routine update services that give you the assurance that the clinical evidence supporting your registrations is being consistently and proactively managed.

The medical device market is both complex and rapidly changing, yet also offers huge opportunity for progressive businesses. PharmaLex Medtech provides due diligence services to companies seeking to diversify their portfolios, and to investment/business consulting firms seeking to understand the highly regulated/technical challenges and opportunities of new medical device or diagnostic ventures. These services range from provision of insight into the regulatory and commercialization environment and predictions as to overall market trends, through to determination of the technical and commercialization challenges for early phase development.

Quality systems are all about the rigor and discipline needed to ensure continuous improvement, compliance and product consistency.
PharmaLex MedTech can ensure that your employees and partners adhere to requirements by means of a global quality management system and can also advise on special-purpose quality management systems for clinical laboratories, R&D facilities or design houses.

Our medical device quality management system expertise helps you follow best practices, adhere to global compliance requirements and adopt a streamlined, consistent approach to managing the system. Whether for ISO 13485 or the FDA’s Medical Device Single Audit Program or 21 CFR 820 FDA QSR compliance, our team can support any medical device or diagnostic project need.

Inspection Readiness

• Avoid panic or surprises or scrambling to prepare
• Let us assist you with your readiness

Preparation makes the difference. Follow the 8Ps!

We can assist throughout the eights steps of preparedness as follows.

1. PURPOSE – Clear and communicated by top management
2. PEOPLE – Defining and taking ownership and accountability
3. PROCESS – Compliant, effective and efficient
4. PRODUCT – Safe, effective and meets client’s needs
5. PHYSICAL ENVIRONMENT – Organized, clean and in control
6. PLANNING AHEAD – Ready at all times for inspection; audit logistics defined and in place
7. PROGRESS – Quality metrics and analysis
8. PRACTICE – PRACTICE – PRACTICE – Mock inspections and audits.

Internal Audits and Preaudit Support

Comprehensive multi-site and multi-scope audit services, including areas for improvement

Preaudit Support

Support to prepare for audits as well as during an audit

Supplier Audits

Virtual or in-person supplier audits throughout the world

Attendance at Regulatory Audits and Observation Resolutions

In most jurisdictions, regulatory agencies insist that a product license be held by a legal entity domiciled within the market — typically, a registered company. The local entity is usually known as a marketing authorization holder, authorized representative or sponsor. The entity takes responsibility for the product on the market, files regulatory submissions and conducts communications with the regulator on behalf of the manufacturer, and therefore, the selection of representative or license holder is critical to the orderly continuation of supply.

PharmaLex MedTech provides authorized-representative services in multiple markets. This is more than an administrative solution: we take charge of the entire regulatory process and provide complete professional management of ongoing compliance so that you can focus on building your business.

As a specialist market representative, we take responsibility for regulatory compliance and provide the interface with regulatory authorities. This gives you the peace of mind that your regulatory compliance is being managed professionally. And it ensures that distribution arrangements are independently structured for maximum commercial benefit.

In most jurisdictions, regulatory agencies insist that a product license be held by a legal entity domiciled within the market — typically, a registered company. The local entity is usually known as a marketing authorization holder, authorized representative or sponsor. The entity takes responsibility for the product on the market, files regulatory submissions and conducts communications with the regulator on behalf of the manufacturer, and therefore, the selection of representative or license holder is critical to the orderly continuation of supply.

PharmaLex MedTech provides authorized-representative services in multiple markets. This is more than an administrative solution: we take charge of the entire regulatory process and provide complete professional management of ongoing compliance so that you can focus on building your business.

As a specialist market representative, we take responsibility for regulatory compliance and provide the interface with regulatory authorities. This gives you the peace of mind that your regulatory compliance is being managed professionally. And it ensures that distribution arrangements are independently structured for maximum commercial benefit.