SUBMISSION/REGISTRATION

As our team and associates were previously from Agencies, our expertise in submission and registration is a pivotal area. Apart from the regular services of submission in its simplest form, Pharmexon is able to provide ongoing strategy and inputs during the process. Our team understands that Agencies are made up of individuals and opinions can vary. Depending on the source of the query we can assist understanding the root cause of such deficiencies and assist in responding, negotiating or even deferring responses to the agencies. We can also assist in making decisions with regards to withdrawals or resubmissions, particularly in the light of transparency laws that currently exist. Our team is also experienced in leveraging other successful MA grants in other parts of the globe to assist in Agencies to make decisions in their own assessments.

Some of the services offered in this area are:

• Fully compliant dossier submission in most regulated regions
• Support(technical, administrative and regulatory) for Deficiency response and coordination
• Facilitation of dialogue with Agencies during registration process
• Support of finalisation of procedure/national phase
• Management of referrals - regulatory and scientific
• Troubleshoot/risk assessment of major concerns - strategy adaptation
• Finalisation of critical texts for marketing purposes
• Assistance in accepting/rejecting post-approval commitments
• Assistance in GMP Inspections, CAPA and communication with Inspectors

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