04 pillar
Regulatory Affairs – Navigating Compliance with Confidence
From regulatory intelligence to market approval, we guide you through every step of the regulatory journey.
Explore our Regulatory Affairs Pillar, a cornerstone of our comprehensive services. We streamline the regulatory process, ensuring your medical device meets all necessary standards and achieves market approval. Read on to discover how we can support your regulatory needs.
Regulatory Affairs Pillar Core Services
- Regulatory iNTELLIGENCE
- Regulatory training & education
- FDA SUBMISSIONS SUPPORT
- global submissions & RegistrationS
- REGULATORY GAP ANALYSIS & REMEDIATION
REGULATORY INTELLIGENCE AND STRATEGY DEVELOPMENT
In-depth regulatory insights and strategic planning to navigate complex regulatory landscapes.
Effective regulatory strategy is crucial for the successful development and commercialization of medical devices. Our services focus on:
- Regulatory Research: Conducting thorough research to stay updated on current regulations and trends.
- Strategic Planning: Developing regulatory strategies tailored to your product and market.
- Risk Assessment: Identifying potential regulatory risks and developing mitigation strategies.
- Regulatory Roadmaps: Creating detailed roadmaps to guide you through the regulatory process.
- Competitive Analysis: Analyzing competitor regulatory strategies to identify opportunities and threats.
Our regulatory intelligence and strategy development services provide the insights and guidance needed to navigate regulatory complexities confidently.
REGULATORY TRAINING AND EDUCATION
Comprehensive training programs to ensure your team is well-versed in regulatory requirements.
Continuous education is key to maintaining compliance and staying ahead of regulatory changes. Our services include:
- Custom Training Programs: Designing training programs tailored to your specific needs.
- Regulatory Updates: Providing updates on the latest regulatory changes and requirements.
- Interactive Workshops: Conducting hands-on workshops to engage and educate your team.
- Online Training Modules: Offering flexible online modules for convenient learning.
- Compliance Culture: Fostering a culture of compliance through ongoing education and awareness.
Our training and education services ensure your team is knowledgeable and compliant with all relevant regulations.
FDA SUBMISSIONS SUPPORT (510(K), PMA, DE NOVO)
Expert support for preparing and submitting FDA applications to secure market approval.
Navigating the FDA submission process can be challenging. Our services are designed to streamline this process:
- 510(k) Submissions: Preparing comprehensive 510(k) submissions to demonstrate substantial equivalence.
- PMA Applications: Developing Pre-Market Approval (PMA) applications for high-risk devices.
- De Novo Requests: Assisting with De Novo requests for novel devices with no predicate.
- Regulatory Meetings: Facilitating meetings with the FDA to discuss submission strategies and requirements.
- Documentation Preparation: Ensuring all documentation is complete, accurate, and compliant with FDA guidelines.
With our FDA submissions support, you can confidently navigate the regulatory pathway and achieve timely market approval.
GLOBAL SUBMISSIONS AND REGISTRATIONS
Navigating the complexities of global regulatory submissions and product registrations to ensure market access and compliance.
Achieving regulatory approval in multiple markets requires a deep understanding of global requirements and meticulous preparation. Our global submissions and registration services provide comprehensive support to help you navigate these complexities. We focus on:
- Regulatory Strategy Development: Crafting tailored regulatory strategies to streamline the submission and approval process in various markets.
- Dossier Preparation: Preparing and compiling comprehensive and compliant submission dossiers for regulatory bodies worldwide.
- Authorized Representative/PRRC: Serving as your Authorized Representative or Person Responsible for Regulatory Compliance (PRRC) in regions requiring local representation.
- Submission Management: Coordinating and managing submissions to regulatory authorities to ensure timely approval and market entry.
- Regulatory Liaison: Acting as a liaison with regulatory agencies to address queries and facilitate a smooth approval process.
- Post-Approval Support: Providing ongoing support to maintain compliance and address any post-market regulatory requirements.
With our global submissions and registration services, you can confidently expand your market reach and ensure your medical device meets all necessary regulatory standards.
REGULATORY GAP ANALYSIS AND REMEDIATION
Thorough analysis and remediation of compliance gaps to ensure regulatory readiness.
Identifying and addressing compliance gaps is critical to maintaining regulatory compliance. Our services focus on:
- Gap Analysis: Conducting detailed analyses to identify gaps in your regulatory processes and documentation.
- Remediation Planning: Developing and implementing plans to address identified gaps.
- Process Improvement: Enhancing regulatory processes to prevent future gaps.
- Documentation Updates: Ensuring all documentation is accurate, complete, and compliant.
- Compliance Monitoring: Continuously monitoring compliance to ensure ongoing readiness.
Our gap analysis and remediation services help you achieve and maintain regulatory compliance with confidence.
Solutions for Every Milestone of Your Journey
Commercializing a medical product is a complex and multifaceted endeavor. At Fission, we’ve developed six Market Access Pillars to support every step of your MedTech venture from concept, to your first sales, and beyond.
If you only need a website designed, quality procedures developed, or a full 510(k) submission, we’ve got you covered.
OUR SERVICES
Market Access Pillars
Design & Development
- Project Management
- Usability Engineering
- Design History File Creation
- Verification & Validation
- Risk Management Planning
Clinical Development
- Clinical Protocol Development
- GCP Compliance
- Clinical Evaluation Reports
- Data Integrity & Management
- Post-Market Clinical Studies
Quality Systems & Compliance
- Quality Management Strategy
- Quality Management Systems
- Mock FDA Inspections
- Regulatory Audit Prep
- Compliance Training
Regulatory Affairs
- Regulatory Strategy
- FDA Submissions Support
- Regulatory Gap Analysis
- Global Submission & Registration
- Regulatory Compliance
Commercialization
- Brand Development
- Strategic Marketing Planning
- Content Strategy & Creation
- Digital Marketing
- Social Media Management
Maintenance
- Post-Market Surveillance
- Continuous Quality Improvement
- Product Lifecycle Management
- Regulatory Reporting
- Complaint Management
At Fission Consulting, we’re not just another consultancy—we’re your dedicated partners in navigating the complexities of the medical device industry. With a team of expert consultants spanning all core service areas, we offer unparalleled expertise and guidance at every stage of your journey, from concept to market dominance.
