Regulatory Services

Pharmaceutical products entering international markets must meet the applicable regulatory requirements of their destination countries. LIHI Pharma supports regulatory-related enquiries by coordinating with relevant manufacturing partners, suppliers, and regulatory service providers, where applicable. Our focus is on facilitating access to relevant product information and documentation required for pharmaceutical trading, exports, and market-specific requirements.

Regulatory requirements may vary according to the product, dosage form, country, and intended use. Documentation, registration status, and submission requirements are therefore assessed on a case-by-case basis. Any regulatory submission, approval, or certification remains subject to the relevant authorities and responsible parties.

Our Regulatory Support Areas Include:

Registration Documentation Support:

Coordination of available product registration documents
Product dossiers and technical documentation, where available
Coordination of applicable product certificates
Certificate of Analysis (COA), where applicable
Certificate of Pharmaceutical Product (COPP), where applicable
Documentation requirements for destination markets

Post-Registration Support:

Coordination of product registration status information
Support for renewal-related documentation enquiries
Coordination of updated product information, where applicable
Collection of relevant documents from responsible partners
Support for documentation related to product changes
Communication with relevant suppliers and service providers

Pre-Registration Support:

Identification of product-specific documentation requirements
Coordination for available technical documents
Product specifications and formulation information, where available
Coordination of documents required for market enquiries
Support for export-related documentation coordination
Communication of country-specific requirements to relevant partners

LIHI Pharma aims to simplify communication between customers and relevant pharmaceutical partners by coordinating product information and applicable documentation enquiries. The availability and scope of regulatory support depend on the product, destination market, and services provided by the responsible partners. Regulatory approvals and market authorizations are granted only by the relevant competent authorities.

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