Outsourcing of all Pharmacovigilance activities to comply with local requirements (Infarmed).
Prospection and approximation between Pharmaceutical and Pharmacochemical companies in Latin America and Europe.
Multidisciplinary support for Pharmaceutical and Pharmacochemical industry’s routine.
Technical and regulatory evaluation and discussion to define strategy for Deficiency Letter response.
Support in the definition of technical-regulatory strategies for submission of MA and/or variations of drug products in Portugal.
Support in the economic evaluation for price definition and reimbursement for medicines approved in Portugal.
Support in the contact and representation of international company to Infarmed.
Preparation and conference of packaging materials, including Mock-ups, Label layout, SmPC and PIL.
Scientific translation of technical documentation or complete dossiers.
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