Medvice Group

Medvice Group LLC offers expertise in affairs related to clinical trials, quality, regulatory, and manufacturing for medical device and pharmaceutical industry. We are a trusted partner for life science companies with well-designed solutions throughout the product life cycle.
A variety of experts can fill your experience gaps at various stages of product life cycle, including;

Manufacturing
• Validation Master Plan, Sterilization validation, biocompatibility, shelf Life testing, packaging design and validation, process and software validation, Factory / Site Acceptance Testing, Development of quality system, risk analysis, test and sampling Plan
• Gap analysis, CAPA System, electronic records and signature, calibration management

Quality
• Quality system regulation, supplier management, quality documentation, training
• Design control, ISO, QSR, EU Directives, quality assurance audits, gap assessment, Due Diligence
• Post market compliance and surveillance, complaint management, CAPA, and risk management

Regulatory
• Regulatory submissions (Pre IDE, IDE, 510(k), PMAs, RFDs, ANDAs, NDAs, DMFs, BLAs, HDE)
• Master Files for Devices (MAF), 513 (g) Requests for Classification, GMP regulatory compliance, mock audits, FDA Inspection Observation (Form 483) or warning letter response
• Labeling specification and review
• US agent representation, Technical Files / Design Dossiers for CE Mark
• ISO 14971 Risk Management and Mitigation, Canadian license application

Clinical Trials
• Adaptive trials designs: Bayesian continual assessment method (CRM),
• Document preparation and management
• Trial monitoring- preparation of data monitoring plan, interim analysis, maintenance of committees, Clinical study planning, design and testing, data management

Therapeutics
• Investigation and review of population, disease, compounds, and regulatory requirements
• Country, site, patient selection, and recruitment
• Development and modification of documents and reports

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