Area of expertise
Product Development & Regulatory Strategy
The regulatory course is set early: classification, conformity route and study design determine what evidence will later be required. We connect product development and regulatory strategy, from design controls and usability through clinical evaluation and performance studies to CMC and approval strategy, so development decisions and regulatory requirements fit together from day one.
- Biotech
- IVD
- MedTech
- Pharma
All topics
19 topics in Product Development & Regulatory Strategy
Biocompatibility Studies →
Biocompatibility evaluation for medical device manufacturers: risk assessment and Biological Evaluation Plan per ISO 10993-1:2018, chemical characterization per ISO 10993-18, coordination of biological test laboratories, and an audit-ready Biological Evaluation Report for the technical documentation under MDR (EU) 2017/745.
Clinical & Medical Affairs →
Clinical & Medical Affairs for pharma, biotech, MedTech and IVD: clinical strategy and evidence planning aligned with regulatory endpoints, clinical evaluation in line with MDR Annex XIV and MEDDEV 2.7/1 Rev. 4, study and protocol planning, and interim staffing of Clinical and Medical Affairs functions.
Clinical Evaluation →
Clinical evaluation and CER preparation for medical device manufacturers under Art. 61 and Annex XIV of the MDR (EU) 2017/745, structured along the five-stage cycle of MEDDEV 2.7/1 Rev. 4: Clinical Evaluation Plan, systematic literature search, equivalence argumentation, evidence synthesis, and integration with PMS and PMCF.
Clinical Monitoring →
Clinical monitoring for sponsors: on-site and remote monitoring by experienced CRAs in line with ICH E6 (GCP), source data verification, tracking of protocol deviations, informed consent review and risk-based monitoring in line with ICH E6(R2). Across drug trials under EU 536/2014 and clinical investigations of medical devices under EU 2017/745.
Clinical Project Management →
Clinical project management for sponsors: operational trial leadership from Phase I through post-market, milestone and budget control, site activation and recruitment management, CRO oversight, and the setup and maintenance of the Trial Master File in line with ICH E6 and the Clinical Trials Regulation (EU) No 536/2014, also available as an interim solution when the trial lead position is vacant.
CMC Strategy →
CMC consulting for pharma and biotech: CMC strategy and development support, authoring and review of CTD Module 3 against ICH Q8-Q10, tech transfer and scale-up, and management of post-approval variations, from early development through authorization and across the lifecycle.
CRO Support →
CRO support for sponsors of clinical trials: a structured RFP and selection process, building a governance and oversight framework, ongoing performance management against defined performance indicators, and a sponsor audit of the CRO in line with ICH E6 Good Clinical Practice, across pharma, biotech, MedTech and IVD.
Cybersecurity for Medical Devices →
Cybersecurity consulting for medical device manufacturers: threat modeling, secure development lifecycle to IEC 81001-5-1, SBOM management and post-market vulnerability monitoring, anchored in the GSPR of the MDR (EU 2017/745), the MDCG 2019-16 guidance and the FDA requirements for cyber devices.
Design Controls →
Design controls consulting for medical device manufacturers: user needs and design inputs per IEC 62366-1, design reviews at defined milestones, verification and validation per ISO 13485:2016 Section 7.3 and FDA 21 CFR Part 820.30, an end-to-end traceability matrix, and a Design History File through to design transfer into production.
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- 500+ projects completed
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Other areas
Market Access, RWE & Reimbursement
Market access, health economics, real-world evidence and pricing and reimbursement strategy.
Regulatory Affairs
Approval and conformity under MDR, IVDR and pharmaceutical law, from the technical documentation to the notified body.
Quality Management & Compliance
QM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.
Supply Chain & Technical Operations
Supply chain, manufacturing, shortage management and technical operations optimization.
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