In the complex pharmaceutical industry, a combination of expertise, care and attention to detail are mandatory for any company that wants to successfully manoeuvre through the bureaucratic and regulatory maze.
COBEX Provides full-fledge Regulatory Affairs services to the Pharmaceutical and Lifesciences Companies for their hassle-free entry into USA, EU and Emerging Markets. We provide Regulatory Intelligence, guidance at all stages of product development, assistance in dossier compilation & filings, follow-up with Regulatory Authorities for approvals, response to queries (dossier related and GMP related, 483s and Warning Letters) and all support for product Life-cycle Management.
Our team of experts audit your facilities, do the gap analysis, suggest necessary remedial measures to ensure compliances with the regulatory requirements and be inspection ready. We do regulatory due diligence for our clients during license acquisition, license divestment, company acquisition and selecting new suppliers.
In the complex pharmaceutical industry, a combination of expertise, care and attention to detail are mandatory for any company that wants to successfully manoeuvre through the bureaucratic and regulatory maze. That’s where COBEX Scientific & Regulatory Affairs team comes in. From the beginning of R&D, through analytical development, to pre- and post-approval regulatory submissions, our team members can guide your project to a successful outcome.
COBEX clients receive all of the latest technical information needed. If you are a manufacturer, you can have confidence that our team is fully versed in the latest FDA and US DEA regulations and guidelines. It’s why we can provide you with keen insight about:
TO PROVIDE END TO END PHRAMA LIFE CYCLE SOLUTIONS AND HELP PHARMA
SECTOR TO PRODUCE INNOVATIVE &
QUALITY DRUGS & MEDICINES AT LOW COST FOR THE WELLBEING OF PEOPLE
TO BECOME THE CHOICEST & PREFFERED WORLD
CLASS PARTNERS AND ASSOCIATES TO FASCILITATE DRUG DISCOVERY & MANUFACTURING