CMC consulting & Regulatory affairs
Cell line to Post Market Surveillance
Services
CMC Regulatory
CMC (Chemistry Manufacturing and Controls) is at the core of most of the Regulatory activities. Over the years, CMC breadth and depth was developed to support several needs of clients, both small and large biopharma.
Product Development
Our expert teams are ready to support you through every step of the pharmaceutical product development process, leveraging our scientific, clinical and commercial expertise to help you maximize value at each stage.
Pharmacovigilance
A broad assessment of drug safety information is pivotal to exceed the success of a clinical study. We provide your projects with comprehensive solutions to maximize success and minimize cost and delays.
Our in-house Chemistry, Manufacturing, and Control (CMC) and regulatory experts can help you navigate the development process, from consulting and submissions to post market requirements.
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Development
Customized integration of QbD to meet your needs. We create a QbD platform to support your development efforts which is fit for purpose with respect to your company size and structure and in line with ICH expectations.
Submission
Our Regulatory Strategy and Submissions Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects.
Training
Our professional experience in the field of clinical research collaborate with project staff to provide crucial knowledge and skills. Neo Biopharm gives GCP and regulatory trainings to pharmaceutical companies, as well as to researchers.