ONIX

ONIX is a recognised leader in the eCTD outsourcing service space. We work with companies across the Clinical Trail Application spectrum, from early stage / pre-clinical to the final stage when clients are seeking full marketing approval. We effectively become embedded as part of our clients in-house Regulatory team to guide them throughout their regulatory submission process. Clients look to us for our expertise to help them understand the regulatory guidelines and confirm that they comply with the Regulatory Health Authority requirements. With our >10 years of experience we are well positioned to advise companies on best practices for successful global submissions.