Regulatory Affairs

TCA has an excellent track record in submitting meticulous Ministry of Health, EC and CA regulatory submissions. We have established close associations with the relevant local health authorities, as well as deep familiarity with GCP guidelines, FDA and EU regulations and sponsor's SOPs. Our expertise guides your clinical trial through an increasingly complex and ever-changing regulatory landscape. We generate your trial's regulatory process including initial and routine site submissions, alleviating the stress on your resources and workload and reducing the margin for submission errors.