welcomeMCP is a provider of inhouse and outsourced development services with a full focus on the full multi-stage development of solutions for clinical, medical and regulatory challenges that companies and clients face in today's world.
MCP provides outsourced expertise in form or consultation and project development. One particular focus of ours at present is the work being done by us in defining, predicting and implementing the standards needed to be met by electronic cigerette companies due to upcoming regulatory requiriments.
MCP has a focus on the development of our own multi-phase projects in the clinical, medical and regulatory sectors. We cover all facets of the project from the design processes to full market research from start to finish. Focused on the development of projects from preliminary feasibility to final setup, it is our aim to make a quantative and qualitative difference in everyday life.Read more
We bring a novel approach to multi-stage development of solutions for clinical, medical and regulatory problems.
- SME Start Up Support
- Medical Device Design
- Project Development
- Clinical Trial Expertise
- cGCP Expertise
- cGMP Expertise
Focus: 21 CFR Part 11 & EU Annex 11
MCP has detailed expertise in all aspects of Data Integrity. The current push by the US and European
Authorities to allign data management into a coherant standard is causing a major push to assess and implement solutions.
With our expertise, we can drive proper assessment, recommendations, implementation and periodic management support of implemented solutions.
- Stage 1: Initial Systems Assessment based on FMEA Approach
- Stage 2: Software and Process Mapping of each Assessed Systems
- Stage 3: Development of Action Plan based on FMEA Mapping
- Stage 4: Implementation of Action Plan
- Stage 4: Post Implemetnation Assessment
21 CFR Part 11 Assessment Harmonisation with EU Annex 11
Software & Process Mapping of Systems