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Overview of Services Delivered by SynapCon Partners

We deliver high-level consultancy services through a network of specialized partners, including CyberActa (USA), GLSA (USA, global), Orton Healthcare Innovation (UK), and Medical Research Management Consulting (MRMC). Additional partners with specific professional or regional expertise may be added as required.

 

CyberActa provides expertise in U.S. regulatory

compliance, data protection, and healthcare technology commercialisation, ensuring that our clients receive consistent, high-quality advisory services across both European and North American regions.

This collaboration enables SynapCon and MRMC to support global studies, U.S. market entry, and cross-border operations with full alignment to FDA, HIPAA, and international regulatory standards.

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Fixed-Price Consultancy Packages (EasyClin / Clinical Ops / Compliance)

(forward-looking, pragmatic, no fluff)

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1./ 2-Day Strategy Sprint: Clinical Digital Readiness

Rapid health check of your clinical digital landscape – from TMF/ISF to eCRF and CDS. In two days, you receive a clear, decision-ready roadmap instead of another long report.

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2./ 3-Day Study Enablement Deep Dive

For teams preparing new trials or scaling up. We design your end-to-end study operating model, including TMF/ISF setup, feasibility workflow and CDS integration.

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3./ 5-Day Digital Trial Architecture Blueprint

A complete architecture for your clinical data systems (CDS) and operations – including vendor strategy, validation approach and implementation roadmap.

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4./ One-Week FastTrack for US/GCC Market Readiness

Focused programme to prepare your digital clinical operations for US and GCC requirements – HIPAA, Part 11, data residency and investor-facing compliance story.

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5./ Fixed-Price TMF/ISF Cleanup & Inspection Preparation

Targeted support to bring your TMF and ISF into inspection-ready shape, reduce findings and make audits more predictable.

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1 

 Regulatory & Compliance Advisory

  • Guidance on EU and US regulatory frameworks (EU-CTR 536/2014, 21 CFR Part 11, ISO 13485/14971/27001, GAMP5, GDPR, SOC2, etc.).

  • Vendor qualification and validation documentation (URS, FS/DS, traceability matrices, VMPs, CAPA, audit preparation).

  • Support in FDA, EMA and other regulatory inspections, ensuring audit readiness and inspection resilience.

2

Clinical Research & Development Expertise

  • Strategic planning and oversight for global clinical trials across therapeutic areas (oncology, rare diseases, sepsis, metabolic disorders, infectious diseases, neurology, cardiology, dermatology, gynecology, etc.).

  • Trial design and protocol review, feasibility assessments, budget and risk modelling.

  • Deployment and optimization of CTMS/eTMF/ISF solutions (EasyClin, EasyTMF, EasyISF, EasyCRF, EasyFeasibility).

  • Integration of advanced technologies such as AI/ML, blockchain, and federated data models into clinical operations.

3

Business Development & Market Access Support

  • Support US-based clients in entering the European market (compliance pathways, digital trial infrastructure, partner ecosystems).

  • Development of collaborations with sponsors, CROs, and patient organizations, with focus on rare and orphan diseases.

  • Advisory on joint ventures, licensing models, and cross-border partnerships.

4

Medical Device Innovation & Growth

  • Product development lifecycle expertise from environmental, user and market need identification, conceptualization, product validation through regulatory approval and commercialization.

  • Advising on ISO13485 frameworks, UKCA, and EU CE-marking, FDA submissions, market and product validation.

  • Strategic planning, fundraising support, risk management and governance frameworks for MedTech SMEs and multinationals.

  • Project and program delivery leadership for complex medical device development and scale-up.

5

Health Data Strategy & Technology Integration

  • Advisory on digital health platforms, data architecture and integration with clinical systems.

  • Health informatics and data governance frameworks aligned with NHS and EU standards.

  • Implementation of interoperability solutions to connect health data across providers and systems.

  • Support in developing patient-centric digital engagement and data analytics solutions.

  • Strategic planning, proposal development, tendering, delivery, and oversight for EU and UK medical device related clinical trials.

  • EU and UK related trial design and protocol review, feasibility assessments, budget, risk modelling and delivery.

6

Strategic & Executive Support

  • Participation in high-level negotiations with biotech and MedTech clients.

  • Ongoing strategic input to CyberActa’s business direction, including market entry, partnerships, and long-term investment frameworks.

  • Executive advisory functions (as “Executive Consultant” or “Strategic Adviser”) to ensure alignment of compliance, technology, and business growth.

Driving Results. Creating Impact. Together.

Lead-In:

SynapCon and MRMC deliver integrated consultancy services across Biotech and MedTech — combining regulatory insight, clinical expertise, and operational execution to turn complexity into clarity, and strategy into outcomes.

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