Our preferred approach to ensuring a robust MDCP development and approval. We join your team as SME right from the outset (or later) and support you all the way to launch and beyond.
From general training on Medical Devices for Pharmaceutical companies to specialized, e.g. MDR, risk management, ISO 13485, UDI, MD software, 21 CFR 820, training for medical device experts.
You have a project – we take over. We do the project management and execution end-to-end, ensuring the right skills are brought in to deliver on time, on quality and on budget.
You have a specific end-goal – we have a solution for you. From mock Article 117 Opinions, audits/due diligence, to building your QMS from scratch, we provide a holistic solution for you, end-to-end.
Guiding pharmaceutical companies through the complexitites of regulatory pathways for targeted therapies
Development and execution of regulatory strategies for biomarker-driven clinical trials.
Regulatory submissions for CDx and targeted therapies
Navigating global regulatory requirements (e.g., EU, US, Asia).
Evolving regulatory frameworks related to precision medicine technologies.
Regulatory strategies for advanced therapy medicinal products (ATMPs) within a precision medicine context.
Streamlining regulatory processes to accelerate the development and approval of precision medicine products
Minimizing regulatory risks and ensuring compliance
Providing strategic guidance to optimize regulatory pathways for personalized therapies
Facilitating successfulinteractions with regulatory agencies
Helping companies to achieve market access for their innovative products
Notified Body Opinion | SaMD | QMS | Borderline Products | Clinical Evaluations
DHF Documentation
Intended Use
Clinical Evaluation
Regulatory Strategy
Article 117 documentation
Risk Management
Quality Agreements/supplier responsibilities
Interactions with Health Authorities
Regulatory strategy definition
Device | IFU | Packaging | Label | Training Material
DHF Documentation
Intended Use
Use Specification
Task & Hazard Analysis
URRA
IFU (clinical and commercial)
Protocols/reports/memos
Stakeholder Management
HFE study/vendor management
Device/Packaging/Labeling manufacturing
Health Authorities interactions
Packaging Design Strategy | Verification Studies | Optimization & Harmonization | Life Cycle Assessments | Sustainability
DHF Documentation
Shipping Verification Activities (Risk Assessment, Protocol, Report)
Material Test Protocols & Reports
Component Specifications
Technical Drawings
Manufacturing Instructions
Stakeholder Management
Shipping Verification study Management
Packaging & Labeling manufacturer
