Services
From Strategic planning through quality system implementation, clinical testing, global regulatory registrations and post market surveillance, it is our goal to help you bring and maintain a safe and valuable product to major medical markets around the world.
Strategic Planning
In the times of intense market competition, rising product development costs, and changing regulatory requirements, the right kind of strategic planning is essential for a competitive edge. BioMedical Strategy’s Regulatory & Clinical affairs experts offer close assistance in developing a comprehensive and tailor-made strategy, while visioning ahead and putting ground to future needs. We identify the relevant regulatory requirements and develop a compliance program fitted for your company’s activity. Building strong regulatory foundations will significantly simplify future challenges and enable your company to stay in compliance. By closely communicating with both the companies and the regulatory authorities, we develop a strategy that coordinates scientific endeavors with regulatory demands, maximizing the cost-effective use of each client’s resources and successfully introducing your product into new global markets.
Regulatory Compliance
Understanding the landscape of the Medical Device and In-vitro Diagnostic Regulations is crucial whether you are seeking FDA clearance, CE, CFDA, or AMAR approval or other. Your device underlying technology, proposed use, medical fields and target markets define the regulatory path, and the pre-clinical and clinical tasks you are obliged to follow. At BioMedical Strategy, through our in-depth understanding of international regulatory processes and vast experience with diverse medical devices, we help you define, build and implement the optimal, most efficient regulatory pathway towards entering new global markets.
The scope of our activity depends on your needs, with services including both pre- and post-approval activities:
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Regulatory Strategy
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Development of compliance pathways for a comprehensive developmental process and least burdensome testing plan
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Design of specific testing protocols and writing of the reports
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Bench
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Ex vivo
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In vivo animal
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Clinical
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Preparation of the submission binder:
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Premarket Notifications 510(k)s, Premarket Approvals (PMA)
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Q-Submission & Investigational Device Exemptions (IDE`s)
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Post-Market Surveillance and Clinical activity
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Technical File for CE marking
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Clinical Evaluation Reports
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Interactive work and support of the company R&D teams
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Communications with the regulatory authorities
Pre Clinical & Clinical Affairs
Throughout your device developmental process, the pre-clinical and clinical phases can be the most expensive and time consuming yet the most essential for successfully entering new markets. Today, the increasing emphasis on clinical data demands continuous proof of safety and efficacy for the notified bodies. At BioMedical strategy, we ensure step by step coordination between the regulatory authorities and the product developers at an early stage to promise an easier and more efficient journey to the market. By creating multidisciplinary teams of professionals with product-specific expertise, we ensure building strong clinical foundations that will significantly simplify future audits and help you maintain regulatory compliance.
Whether the intent is to obtain market approval, improve reimbursement, post-market clinical follow-up or generate publications, our highly qualified team of experts provides dedicated support in all aspects of pre and post market clinical studies.
Our comprehensive clinical activities include:
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Strategy Development
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Design of in vivo animal study
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Generation of a Clinical Investigation Package
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Design of the Study Protocol
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Case Report Forms [CRFs]
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Investigator Brochure
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Informed Consent & other administrative material
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Site & Investigator agreements
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Clinical Standard Operating Procedures [SOPs]
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Submissions to Ethical Committees & Regulatory Authorities
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Clinical Study Conduct and Monitoring
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Generation of intermediate and final study reports
Post Market Surveillance
To maintain compliance with medical regulations requires companies to engage in strong post market surveillance activity. PMS is essential not only for providing constant proof for the regulatory authorities that your product can be still claimed as safe and efficient, but also for manufacturers to receive feedback from clinical activity and ensure constant improvements and keeping a competitive edge. In depth understanding of clinical experience with your product provides insight into clinical safety and performance. At BioMedical Strategy, we believe in creating a systematic, proactive PMS approach that consists of qualitative and quantitative feedback from users, engaging in industry educational events and keeping up to date with relevant publications. Our team of professionals will support you build strong and efficient PMS foundations to create a valuable, cost effective compliance system, assuring product quality and safety.
Project Management & Developmental Support
Adequate project management strategies are essential and in particular for the successful introduction of innovative medical products into new markets. Effective policies help address regulatory compliance and get faster approvals. Although project management is crucial for the success of any business, it is especially vital for the manufacturers of medical products due to the complex nature of international regulatory authorities and ever-changing requirements. BioMedical Strategy can help develop the right kind of project management matrix while visioning long term goals and building the proper infrastructure to realize them.
Quality Assurance
Companies planning to introduce their medical products to various global markets must adhere to high quality and process control standards. Today’s quality assurance demands from medical product manufacturers are quite challenging. As the ISO 13485 states; manufacturers must be consistently able to meet the quality demands of both the regulatory bodies and clients. At BioMedical Strategy, we design, build and implement quality management systems (QMS) for organizations of all sizes across the Life Sciences industry. Our quality systems consulting experts will work within your organization to create and improve your internal processes, assuring in house understanding of the quality requirements to facilitate the product- to -market process. Together, we guarantee your medical product stays in compliance throughout its lifecycle.