OUR SERVICES
For each service:
Operational stakeholders and a team of experts dedicated to the project.
OUR SERVICES
For each service:
Operational stakeholders and a team of experts dedicated to the project.
Operational stakeholders and a team of experts dedicated to the project.
PHARMACEUTICALS & BIOTECHS
PHARMACEUTICALS & BIOTECHS
AlisPharm supports the pharmaceutical and biotechnology industries in the development of their products and processes, with a solid quality and regulatory expertise «To do it Right the First time».
AlisPharm supports the pharmaceutical and biotechnology industries in the development of their products and processes, with a solid quality and regulatory expertise «To do it Right the First time».
AlisPharm supports the pharmaceutical and biotechnology industries in the development of their products and processes, with a solid quality and regulatory expertise «To do it Right the First time».
01 OPERATIONAL QUALITY ASSURANCE
02 QUALITY MANAGEMENT SYSTEM
03 INDUSTRIAL TRANSFER
04 COMMISSIONING & ENGINEERING
05 VALIDATION OF COMPUTERIZED SYSTEMS
06 VALIDATION OF AUTOMATED SYSTEMS
07 QUALITY CONTROL
08 REGULATORY AFFAIRS
09 PHARMACOVIGILANCE & CLINIC
10 PROCESS VALIDATION
11 EQUIPMENT QUALIFICATION
OPERATIONNAL QUALITY ASSURANCE
• Processing Quality Events / NC / CAPA / Change Control
• Coordinating quality action plans
• Quality management with suppliers, production and laboratories
QUALITY MANAGEMENT SYSTEM
• Creating and reviewing the QMS according to the BPF/GMP
• Preparing audits and managing post-audit answers
• Training, awareness and supporting staff in the quality process
INDUSTRIAL TRANSFER
• Management of inter- and intra-site transfers (complete lines or equipment relocation)
• Scale up, scale down
• Analytical transfer, technological transfer
COMMISSIONING & ENGINEERING
• User needs, drafting the requirements specifications, defining the specifications
• Purchase and installation of equipment, automated systems, utilities, premises
• Suppliers, installation and testing management
VALIDATION OF COMPUTERIZED SYSTEMS
• Validation of computerized systems (GAMP5 environment, 21CFR part11)
• ERP, GED, automated and embedded systems
• Integration, software, unit and non-regression tests
• Data Integrity Projects (traceability, access, audit trail)
VALIDATION OF AUTOMATED SYSTEMS
• Production and Laboratory Systems (PLC, IHM) and SCADA Supervision
• Audit trail, access management, data saving, back-up, restore
• VMP, protocols, reports
QUALITY CONTROL
• Analytical and microbiological development and validation
• Analysis of test results, management of OOS
• Data integrity project, LIMS installation
REGULATORY AFFAIRS
• Marketing authorization applications (MAA) files
• Modules 2, 3, 4 and 5 (CTD and e-CTD format)
• Responses to health authorities of different countries
PHARMACOVIGILANCE & CLINIC
• Management of adverse events, adverse reaction (AR) reports
• Writing PV reports (PSURs)
• Product benefit/risk management
PROCESS VALIDATION
• Optimizing manufacturing and cleaning processes
• Experience plan, statistical process control tools
• Validation of manufacturing, cleaning, sterilization, packaging processes
• Strategies and worst cases (equipment, product) definition
EQUIPMENT QUALIFICATION
• Laboratory and production equipment, utilities, premises
• FAT, SAT, IQ, OQ, PQ
• VMP, protocols, reports
01 OPERATIONNAL QUALITY ASSURANCE
02 QUALITY MANAGEMENT SYSTEM
03 INDUSTRIAL TRANSFER
04 COMMISSIONING & ENGINEERING
05 VALIDATION OF COMPUTERIZED SYSTEMS
06 VALIDATION OF AUTOMATED SYSTEMS
07 QUALITY CONTROL
08 REGULATORY AFFAIRS
09 PHARMACOVIGILANCE & CLINIC
10 PROCESS VALIDATION
11 EQUIPMENT QUALIFICATION
OPERATIONNAL QUALITY ASSURANCE
• Processing Quality Events / NC / CAPA / Change Control
• Coordinating quality action plans
• Quality management with suppliers, production and laboratories
QUALITY MANAGEMENT SYSTEM
• Creating and reviewing the QMS according to the BPF/GMP
• Preparing audits and managing post-audit answers
• Training, awareness and supporting staff in the quality process
INDUSTRIAL TRANSFER
• Management of inter- and intra-site transfers (complete lines or equipment relocation)
• Scale up, scale down
• Analytical transfer, technological transfer
COMMISSIONING & ENGINEERING
• User needs, drafting the requirements specifications, defining the specifications
• Purchase and installation of equipment, automated systems, utilities, premises
• Suppliers, installation and testing management
VALIDATION OF COMPUTERIZED SYSTEMS
• Validation of computerized systems (GAMP5 environment, 21CFR part11)
• ERP, GED, automated and embedded systems
• Integration, software, unit and non-regression tests
• Data Integrity Projects (traceability, access, audit trail)
VALIDATION OF AUTOMATED SYSTEMS
• Production and Laboratory Systems (PLC, IHM) and SCADA Supervision
• Audit trail, access management, data saving, back-up, restore
• VMP, protocols, reports
QUALITY CONTROL
• Analytical and microbiological development and validation
• Analysis of test results, management of OOS
• Data integrity project, LIMS installation
REGULATORY AFFAIRS
• Marketing authorization applications (MAA) files
• Modules 2, 3, 4 and 5 (CTD and e-CTD format)
• Responses to health authorities of different countries
PHARMACOVIGILANCE & CLINIC
• Management of adverse events, adverse reaction (AR) reports
• Writing PV reports (PSURs)
• Product benefit/risk management
PROCESS VALIDATION
• Optimizing manufacturing and cleaning processes
• Experience plan, statistical process control tools
• Validation of manufacturing, cleaning, sterilization, packaging processes
• Strategies and worst cases (equipment, product) definition
EQUIPMENT QUALIFICATION
• Laboratory and production equipment, utilities, premises
• FAT, SAT, IQ, OQ, PQ
• VMP, protocols, reports
MEDICAL DEVICES
MEDICAL DEVICES
In a constantly evolving regulatory environment, AlisPharm guides the medical devices manufacturer throughout its product lifecycle, to meet the expectations of health authorities and enable a reliable marketing launch.
In a constantly evolving regulatory environment, AlisPharm guides the medical devices manufacturer throughout its product lifecycle, to meet the expectations of health authorities and enable a reliable marketing launch.
In a constantly evolving regulatory environment, AlisPharm guides the medical devices manufacturer throughout its product lifecycle, to meet the expectations of health authorities and enable a reliable marketing launch.
