Pharmaffairs Pharmaceutical Consulting
Pharmaffairs is a regulatory and scientific consultancy company focused on the pharmaceutical industry, healthcare, medicinal, and health products. It provides specialized services with a team experienced in the sector, aiming to support clients with quality, confidentiality, and flexibility, ensuring compliance with timelines. The company offers services in regulatory support, pharmacovigilance, registration dossiers, and more, both in Portugal and internationally, with a commitment to quality and continuous improvement.
Industries
Nr. of Employees
small (1-50)
Pharmaffairs Pharmaceutical Consulting
Products
scientific regulatory
Scientific and regulatory support services provided on a regular, sporadic, or project basis to fulfill demanding timelines in the pharmaceutical and healthcare industry.
SCIENTIFIC AND REGULATORY OPINION
Strategic consulting for new products, submissions, regulatory pathways, data evaluation, and project management.
PHARMACOVIGILANCE
End-to-end or specific pharmacovigilance services compliant with GVP, including QPPV services, safety reporting, risk management, and audits.
eCTD/NeeS
Document structure analysis, preparation, integration in eCTD/NeeS format, hyperlink creation, and maintenance services.
REGISTRATION DOSSIERS
CTD elaboration and reformat MA dossiers.
MARKETING AUTHORIZATIONS
Services covering national, mutual recognition, decentralised, centralised procedures applications, parallel import applications, and early access programs.
scientific regulatory
Scientific and regulatory support services provided on a regular, sporadic, or project basis to fulfill demanding timelines in the pharmaceutical and healthcare industry.
SCIENTIFIC AND REGULATORY OPINION
Strategic consulting for new products, submissions, regulatory pathways, data evaluation, and project management.
PHARMACOVIGILANCE
End-to-end or specific pharmacovigilance services compliant with GVP, including QPPV services, safety reporting, risk management, and audits.
eCTD/NeeS
Document structure analysis, preparation, integration in eCTD/NeeS format, hyperlink creation, and maintenance services.
REGISTRATION DOSSIERS
CTD elaboration and reformat MA dossiers.
MARKETING AUTHORIZATIONS
Services covering national, mutual recognition, decentralised, centralised procedures applications, parallel import applications, and early access programs.
Services
End-to-end support for marketing authorisation applications (national, decentralised, mutual recognition and centralised), parallel imports, exceptional use and early access procedures; multi-state procedure coordination.
CTD dossier authoring and reformatting, structured eCTD/NeeS integration using validated software, hyperlinking and delivery of submission-ready packages, plus ongoing dossier maintenance.
Customised PV solutions including PV system development, PSMF creation, safety database registration, electronic reporting, QPPV and local contact roles, PSURs, RMPs, signal detection and inspection support.
Preparation and submission of clinical trial applications to competent authorities and ethics committees, management of national submission platforms and clinical trial PV activities.
Design, implementation and maintenance of ISO 9001-aligned Quality Management Systems; continuous improvement, risk assessment and corrective/preventive actions; regulatory compliance assessments and due diligence.
Support to Quality Assurance and Technical Direction functions, including acting as technical/responsible person for distribution, GDP wholesaler authorisation assistance, quality audits and inspection preparedness.
End-to-end support for marketing authorisation applications (national, decentralised, mutual recognition and centralised), parallel imports, exceptional use and early access procedures; multi-state procedure coordination.
CTD dossier authoring and reformatting, structured eCTD/NeeS integration using validated software, hyperlinking and delivery of submission-ready packages, plus ongoing dossier maintenance.
Customised PV solutions including PV system development, PSMF creation, safety database registration, electronic reporting, QPPV and local contact roles, PSURs, RMPs, signal detection and inspection support.
Preparation and submission of clinical trial applications to competent authorities and ethics committees, management of national submission platforms and clinical trial PV activities.
Design, implementation and maintenance of ISO 9001-aligned Quality Management Systems; continuous improvement, risk assessment and corrective/preventive actions; regulatory compliance assessments and due diligence.
Support to Quality Assurance and Technical Direction functions, including acting as technical/responsible person for distribution, GDP wholesaler authorisation assistance, quality audits and inspection preparedness.
Expertise Areas
- Regulatory submissions and lifecycle management
- Pharmacovigilance and drug safety
- eCTD and electronic dossier management
- Quality management systems (ISO 9001)
Key Technologies
- eCTD / NeeS electronic submission format
- Common Technical Document (CTD) dossier structuring
- Electronic safety reporting and safety database interfaces
- Signal detection and safety monitoring methodologies