REGULATORY AFFAIRS


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

CLINICAL CONSULTING


CLINICAL STRATEGY

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

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

quality management systems


QMS DESIGN AND IMPLEMENTATION

ISO 13485 AND 21 CFR PART 820 TRAINING

INTERNAL AUDITS

2ND AND 3RD PARTY AUDITS

Call or email the team 

+44(0) 28 8674 7624