Services2018-09-11T23:28:09+00:00

OUR SERVICES

The services provided by Pharmaffairs comply with all regulatory and technical scientific applicable requirements which are integrated into the company’s Quality Management System, involving all departments and services, thus fulfilling the international requirements of ISO 9001: 2015 standard.

Certification

The services of Pharmaffairs will enable the entry, management and maintenance in the Portuguese market
of your portfolio.

Pharmaffairs will make the bridge to other markets, based on a team of Specialized professionals.

• National procedures applications
• Mutual Recognition Procedure applications (Portugal acting as Reference Member State or as Concerned Member State)
• Decentralised Procedure applications (Portugal acting as Reference Member State or as Concerned Member State)
• Centralised procedures applications
• Parallel import applications
• Exceptional Use Authorisation (“AUE” applications, batch use “AUE” application, Commercialization of medicinal products without MA granted in Portugal Use application “SAR”)
• Early Access Program (EAP) application

Pharmaffairs is your partner of excellence if you need the approval of a procedure in multiple Member States. Pharmaffairs also provides support in the analysis, submission, monitoring and finalization of the procedure.

Pharmaffairs has experience in specific areas such as:
– Medicinal product gases;
– Homeopathic medicinal products;
– Herbal medicinal products

CTD elaboration and reformat MA dossiers

• Variation Type IA, IAIN, IB and II;
• Labelling elaboration and analysis (SPC, PIL and Label);
• MA dossier CTD adaptation/restructuration;
• MA renewal;
• MAH transfer.

• Document structure analysis and preparation;
• Document integration in eCTD/NeeS format according to specific and validated (licensed) software;
• Hyperlink creation;
• Project delivered in “ready for submission” format;
• Maintenance and update services of MA dossiers in eCTD/NeeS format.

Pharmaffairs provides the eCTD / NeeS service through a consolidated experience over the years with the implementation and use of state-of-the-art software and accepted in all Member States.

• Promotional and non-promotional material medical and regulatory review and approval;
• Notification of promotional materials support and management;
• Opinion related to promotional activities;
• Notification of promotional activities support and management.

• New product’s strategies;
• Submission strategies;
• Regulatory strategies opinion/assessment;
• Data analysis/evaluation;
• Project management.

Pharmaffairs Pharmacovigilance services are performed according to the GVP and all applicable legislation and guidance, customised to your needs (“end-to-end” solution or specific support to a given sub-area).

• Pharmacovigilance Quality System development, implementation and maintenance;
• EudraVigilance registration;
• Electronic reporting;
• Pharmacovigilance System Master File development and maintenance;
• Article 57 of EU Regulation 726/2004 registration and maintenance activities;
• QPPV services;
• Local contact person for Pharmacovigilance;
• Periodic Safety Reports Updates;
• Urgent Safety Measures management, implementation and ongoing support;
• Pharmacovigilance procedures elaboration;
• Risk Management Plan elaboration, implementation and maintenance;
• RLocal and International medical/scientific Literature search;
• Pharmacovigilance audits;
• Support in Pharmacovigilance inspections;
• Medicinal product safety profile monitoring (including GVP signal detection);
• HealthCare Professional Communication and Educational Materials (including elaboration, review, approval (communication with Health Authority), implementation and effectiveness monitoring);
• Pharmacovigilance training (specific training needs identification, training materials development, knowledge evaluation, training “refresh” and monitoring of training efficacy);
• Medical Inquiries management.

• Complete Readability Test development in “ready to submit” format;
• Bridging reports elaboration in “ready to submit” format.

• ISO 9001 Quality Management System development, implementation and maintenance.

• Price applications;
• Annual price review application;
• Exceptional Price review application;
• Change price application – Notified price regime;
• Reimbursement application.

• Submission of Applications for Certificates of a Pharmaceutical Product (WHO Model) to National Health Authority (INFARMED);
• Legalization of Certificates of a Pharmaceutical Product by embassies/consulates in Portugal.

• Support to Quality Assurance/Technical Direction activities (including acting as GDP QP) Elaboration and implementation of Quality Management Systems;
• GDP Wholesaler activity application (including medicinal products gases);
• Quality audits;
• Support in Quality Assurance inspections.

• Regulatory Compliance project assessment and presentation of action plan;
• Corrective and preventive measures plan implementation (including MA variation elaboration, if applicable);
• Due diligence.

• Clinical Trial application submission to INFARMED, IP;
• Clinical Trial application submission to CEIC (Ethic Committee);
• RNEC platform management;
• Clinical Trial Pharmacovigilance activities.

• Evaluation support to Medical Device Conformity;
• Medical Device registration;
• Medical device classification evaluation support;
• Life-cycle maintenance activities;
• Technical Responsible activities;
• GDP Wholesaler activity application;
• Quality audits;
• Support to Quality inspections;
• Medical devices publicity (including promotional material review and approval and promotional activities assessment and support);
• Medical Device Vigilance;
• Support to health technology evaluation.

• Labelling conformity evaluation of food supplements according to the Portuguese and European Legislation;
• Food supplement notification application;
• Life-cycle maintenance activities;
• Elaboration, submission, management and maintenance National code application;
• Food supplement publicity;
• Food supplements vigilance.

• Cosmetic conformity evaluation support;
• Cosmetic registration;
• Life-cycle maintenance activities;
• Cosmetic publicity;
• Cosmeticvigilance.

OTHER SERVICES

• Technical Translations
• Training by recognized trainers
• Medical Sales Representatives Training by recognized trainers

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