01
Product Registration
Manage and support pharmaceutical product registration, licensing and related regulatory requirements.
Regulatory affairs
Commitment to pharmaceutical compliance
Our Regulatory Affairs function supports product registration, licensing, documentation, coordination and market authorization activities.
Regulatory support
Coordinated support for product access
Our work supports the regulatory activities required for pharmaceutical products supplied in Nepal.
This includes registration, licensing, documentation, coordination with relevant authorities, import permits and market authorization activities.
02
Regulatory Compliance
Ensure compliance with applicable laws, regulations, guidelines and internal company policies relevant to pharmaceutical operations.
03
Authority Liaison
Maintain appropriate communication and coordination with relevant regulatory authorities for regulatory submissions, approvals, permits and other requirements.
04
Documentation
Review, maintain and manage regulatory documents required for product registration, licensing, importation and ongoing compliance.
05
Import Permits
Manage and coordinate import permits, special permits and other required regulatory permissions associated with pharmaceutical products to meet the dire need of each and every individual patient.
06
Market Authorization Holder (MAH)
Prime Life Care International executes the function and responsibility as marketing authorization holder - MAH as required by principal companies with regard to business ethics and integrity, quality and safety of medicines including pharmacovigilance.
Prime Life Care International