Regulatory submissions

Clinical Consulting provides transparent regulatory services for pharmaceuticals and medical devices.

Clinical Consulting Regulatory Affairs team

has dedicated resources which enable us to provide regulatory solutions to suport with a wide range of regulatory affairs encountered in preparation and throughout the conduct of each clinical trial.

Regulatory Services

  • Regulatory Strategy & Development Planning
  • Competent Authority and Ethic Committee submissions and communication.
  • Regulatory/ GMP Compliance

Our experience includes:

COUNTRY SELECTION
and local regulatory consultancy and timeline guidance
LIAISON
with local regulatory authorities, EMA agency, Institutional Review Boards, and Ethics Committees in EU countries
APPLICATION PREPARATION
REGULATORY DOCUMENTS
Creation, preparation, execution and maintenance of regulatory documents for submission to industry sponsors, ethics committees, and regulatory authorities

Our approach is:

Strategic analysis
of the appropriate regulatory needs
Advanced planning
to meet timelines
Agency
communications
Compliance
with regulations

Our partners

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HEADQUARTER

ul. Dzwonkowa 104

43-100 Tychy, Poland

+48 32 227 20 05

office@clinicalconsulting.pl

WARSAW OFFICE

Al. Jana Pawla II

27 00-867 Warszawa, Poland

+48 32 227 20 05

rental@clinicalconsulting.pl

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