SOLUTIONS BASED services
We customized each service based on your need.
Regulatory Consulting Services
At Trinity M Consulting, we focus in staying up to date with latest regulations and industry news. Our experts are experience in Regulatory Strategy, Regulatory Information Management, and Regulatory Submissions.
Regulatory Strategy:
- Regulatory Pathways Analysis
- Industry Guidance and Trainings
Regulatory Information Management:
- Support with Regulatory Data (Pre-market, Market Access, and Post-market)
- Support with Regulatory Project Management, Data Trending, and Tracking
Regulatory Submissions and Registrations:
- FDA Pre-Submission (Q-sub)
- 510(k)s
- Post Market Approval (PMAs)
- New Drug Applications (NDAs)
- Investigational New Drug (IND) Application
- EU MDR and UKCA Submissions
- Market Registrations (India, EMEA, UK, Canada, LATAM, APAC)
Project Management Services
Our Project Managers are experts in the field with experience in Problem Solving, Time Management, Effective Communication, Subject Matter Expertise, Risk Awareness, and Client Relations. We offer a competitive and customized approach to fit small to large size companies.
Project Management and Tools:
- Development of Project Documentation (Charters, Project Plans, and Other)
- Lean Processes Implementation and Training
- Project Team Management (Resources Analysis, Leadership Communications and Presentations)
- Project Tracking Activity and Reporting
- Process Validation and Implementation
- Customized Project Tools
Clinical Trial Services
Our Clinical Consultants are experts in the field with experience with global regulations, project management, and data analysis to better support your clinical trials and to customize services according to your needs.
Clinical Trials Services:
- Development of Study Documents (Protocols, Brochures, Consents, Marketing Materials and Other)
- Phase I – Phase III Clinical Trial Oversight
- Support with Informed Consent Documentation process
- Support with IEC / IRB Submissions
Market Access
We support Market Access registrations for your device or drug within the United States or Globally.
Looking for an EU Authorized Representative or Person Responsible for Regulatory Compliance?
A European Authorized Representative is defined as being any natural or legal person within the European Union who has accepted a written mandate from a non-EU manufacturer to act on their behalf in relation to specified tasks under MDR or IVDR. We can help assigning your EU Representative or Person Responsible for Regulatory Compliance.
Medical Writing
Our Medical Writers are experts in the field with extensive experience in the Clinical and Regulatory.
Medical Writing Services:
- Support with EU MDR Documentation (review and write-up)
- Support with Clinical Analysis and Write-up
- Industry Guidance and Documentation Templates
- Clinical Evaluation Report (CER)
- Summary of Safety and Clinical Performance (SSCP)
- Post-Market Surveillance Reports
- Clinical Submission Write-up
- Regulatory Surveillance Documents
- Marketing Documents and Presentations
Need Help with assigning a EU Representative or PRRC?
We can help!
Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostics Medical Device Regulation (EU IVDR 2017/746) both state that where a “non-EU” manufacturers whom wishes to place a medical device in the European market must have a designated Authorized Representative. At Trinity M Consulting, we can help with designating your EU Authorized Representative or Person Responsible for Regulatory Compliance.
We commit in providing the best services for your company. We take pride in creating a partnership with our clients and delivering excellence.
