Global Compliance
Global Compliance
The journey of pharmaceutical Drug /Medical devices from development to commercialization involves several steps that are completely governed and regulated by global health authorities. Ensuring Regulatory compliance throughout the process is a mandatory requirement, and to take care of the procedures across the product life cycle, our organization deploy proven experts for Regulatory Affairs to comply with national and international regulations.
At Career Prime, our consultants play a bridge between organizations and key regulators like US FDA, ICH, PMDA & European Health Authorities, etc.
Career Prime consultants, can bring extensive regulatory expertise to your organization but not limited to:
- Regulatory submissions, Clinical Trials, Regulatory Writing, and Product Clearances.
- Approval of Pre-market notifications (510(k)), Pre-market Approval supplements.
- Submission of eCTD, and Design dossiers, responding to 483’s, Handling Audits.
- EU MDR regulatory compliance, Post Market Surveillance, cGMP, STED, PMCF, CER’s
- Submission of NDA, IND, and ANDA application and comply with International regulations, etc.
“Your trust – Our Quality”
At Career Prime, we understand the needs of clients, thus we strive to supply the best of the consultants to clients as per their skillsets and experience.
177 Center Point Rd,
Suite 104, Weatherford
Texas 76087
+1 656 2074158
hr@careerprimesolutions.com
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