Complex Expertise
Get in touch
555-555-5555
mymail@mailservice.com
Systems Approach to Solution Development & Implementation
Contact Us
T: +1-(631)-791-8129
Pharmaceutical and Medical Device Consulting
One-Stop-Shop for Placing Your Medical Devices on the European Market
Holistic Approach
Exceptional Record
Optimized Mitigation blends Policy, Procedures, Staffing, Technology and Training.
One-Stop Shop for Placing Your Medical Devices on the EU Market
We have an exceptional record in preparing submissions for certification of medical devices on the EU market. We offer assistance with preparing technical documentation required for regulatory submissions in the European Union in compliance with EU MDR 2017/745. We assist manufacturers in preparing technical documentation for submission to EU notified bodies and national regulatory authorities to certify their medical devices in compliance with Medical Devices Regulation (EU) 2017/745. Our team has an excellent record in preparing documentation that successfully passes the certification process. Additional services include notification and follow-up with national competent authorities and notified bodies.
Our Team has an exceptional record of successful submissions.
Research Support in the Pharmaceutical and Medical Device Sectors
We provide custom research to satisfy compliance obligations and support decision-makers in the pharmaceutical and medical device sectors. We cooperate with the Client to define research strategy and objectives to serve business needs. On behalf of our clients, we perform screening of relevant data sources, including scientific literature, and prepare summaries and compile reports for regulatory submission or internal purposes.
For Device manufacturers, we screen scientific literature and compile summaries to support clinical evaluations, post-market clinical follow-up, and biocompatibility assessments.
We support literature screening and summaries for PSURs (GVP Module VII), DSUR (ICH E2F), study protocols, and ad hoc background research for the Pharma industry. We provide CONSORT-compliant study summaries, Summary of Findings tables, and grade evidence using Cochrane tools.
We provide scientific information support for management boards and investors in the life science, medical technology, pharma, and biotech sectors.
Training Solutions in the Medical Device and Pharma Sector
We design, develop and implement training solutions based on an analysis of your organization's needs. In collaboration with the Client, we analyze tasks required to perform the job competently, define performance standards, draft curriculum, prepare blueprints for training, and develop training materials and evaluation strategies. We increase organizational resilience by building in-house expertise to make your workforce more agile, efficient, and better prepared to cope with change.
Pharmaceutical Supply Chain Security & Integrity
Operational Risk Management
Full-spectrum multi-service and inter-agency operational plans and policy with proven ability to implement and improve programs through broad-based competencies in
- All Source Intelligence Collection Planning, Management, Analysis
- Analysis determining vulnerabilities of industrial infrastructures and social institutions
- Decision-Making Process/Analytical Problem Solving
- Deliberate and Crisis Action Planning
- Training and Exercise Development/Systems Approach to Training (SAT) and Simulations
- Special Operations, unconventional warfare (UW), counter-insurgency (COIN), counter-terrorism (CT), Civil-Military Operations (CMO), PSYOPS, Evasion, and Recovery (E&R)
Specialties include mapping and assessment of complex organizational relationships and operational interdependencies to determine potential vulnerabilities in policy, plans, procedures, training, staffing, and job task distribution that directly support organizational effectiveness for competitive agility, business resiliency, and preparedness for continuity of operations.