Outsourcing of all Pharmacovigilance activities to comply with local requirements (Infarmed).
Prospection and approximation between Pharmaceutical and Pharmacochemical companies in Latin America and Europe.
Ongoing Regulatory Support
Multidisciplinary support for Pharmaceutical and Pharmacochemical industry’s routine.
Support for Deficiency Letter response
Technical and regulatory evaluation and discussion to define strategy for Deficiency Letter response.
Strategy and Regulatory Intelligence
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.
Contact and representation of the company
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.