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companion diagnostics


REGULATORY AND CLINICAL STRATEGY DEVELOPMENT

US FDA SUBMISSIONS: RISK DETERMINATIONS, PRE-SUBMISSIONS, PMA

IRB/IEC SUBMISSIONS

CLINICAL SITE SET UP

GLOBAL CLINICAL SITE MONITORING

ANNEX VIII DECLARATIONS

CLINICAL CONSULTING


CLINICAL STRATEGY

CLINICAL SITE MONITORING
​CLINICAL DATA REQUIREMENTS
CLINICAL EVALUATIONS 
GCP TRAINING AND COMPLIANCE 
POST-MARKET CLINICAL FOLLOW-UP

quality management systems


QMS DESIGN AND IMPLEMENTATION

ISO 13485 AND 21 CFR PART 820 TRAINING

INTERNAL AUDITS

2ND AND 3RD PARTY AUDITS

Regulatory Consulting

REGULATORY AFFAIRS


US - 510(K) AND PMA SUBMISSIONS
​PRE-SUBMISSIONS
CE TECHNICAL FILES AND DESIGN DOSSIERS 
HEALTH CANADA LICENSE APPLICATIONS 
INTERNATIONAL REGISTRATIONS

Call or email the team 

+44(0) 28 8674 7374

MEDICAL DEVICES AND DIAGNOSTICS