Regulatory Affairs

Pharma

PhC provides support in preparation and audit of submission documents (CTD ; active link to definition and pyramide scheme). Furthermore, support is provided with respect to compliance with cGMP and GDP (auditing, GAP analysis and maintenance). Finally, we support our clients in preparation of audits or meetings with National Competent Authorities and take over roles of Responsible Person (FvP) or QP on a contract base.

MedTech

• Preparation of Technical Dossier, Device Master Files and submission to notified bodies / FDA.
• Pursue of biological risk assessment, definition of roadmaps for biocomatibility testing according ISO 10993 series and evaluation of biological risks for all device classes.
• Implementation of risk management policy according to ISO 14971, support in Hazard analysis, FMEA and root cause analysis.
• Definition and support in Post Market Surveillance.
  Support in preparation of re-certifcation audits and interactions with Notified Bodies.

Quality Assurance

Pharma

• EU-cGMP QMS
• CAPA, Deviation Management
• Validations / Qualifications
• GDP

MedTech

• ISO 13485 compliance
• Change Management
• Validations/ Qualifications

Coaching

• StartUPs in Life Science (Pharma/ Biotech/ MedTech)
• Businessplan evaluation
• Regulatory and Reimbursement roadmaps
• Approaching investors / Elevator Pitch Training
• CTI
• HTGF
• Interim Management