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.

PHARMACEUTICALS & BIOTECHS

PHARMACEUTICALS & BIOTECHS

Alispharm Pharmaceutique & 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 Pharmaceutique & 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 Pharmaceutique & Biotechs
Alispharm Pharmaceutique Biotechs

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

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.

Alispharm Dispositifs Médicaux
Alispharm Dispositifs Médicaux

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.

Alispharm Dispositifs Médicaux
Alispharm Dispositifs Médicaux

REGULATORY AFFAIRS

Writing and updating CE/510k marking files
Regulatory monitoring
Provide answers to questions from notified bodies and health authorities
Export submission (worldwide)

RISK MANAGEMENT

AMDEC Methodology (pFMEA) on products and processes
Defining the risk management plan and updating/creating the RMF
Benefits/risks documents

DESIGN TRANSFER

Design input, output, verification and documents validation
Writing and updating DMR/DHF/DHR
Management of the exchanges between R&D and production
Methods/industrialization: setting up inspection plans

QUALITY MANAGEMENT SYSTEM

Creating and reviewing the QMS according to ISO 13485 (current version)
Preparing audits and managing post-audit answers
Training, awareness, and supporting staff in the quality process

SYSTEM ENGINEERING

Management of electromedical systems (specifications, test plan, tests)
V&V according IEC 62304, 60601 norms
Writing technical and functional specifications, CDC, URS

AUDIT & CONSULTING

Quality and regulatory audit
Support the implementation of actions plan
Change management support

MEDICAL DEVICES REGULATION

Monitoring customer sites to ensure their compliances with new regulations
PMS, UDI, clinic, reclassification of medical devices
Change control management, implementation of changes

CLINICAL & BIOLOGICAL EVALUATION

Writing clinical and biological evaluation reports
Data recovery (clinical studies or in vivo and in vitro trials data), bibliographic research
Compliance with MEDDEV 2.7.1 rev4 and MDR

SPECIAL PROCESS VALIDATION

Cleaning, conditioning of MDs, sterilization (ETO, gamma, autoclaves), laser marking and engraving, etc.
Strategies, worst cases and sampling plans definition
Trials management with subcontractors

VALIDATION OF COMPUTERIZED SYSTEMS

Validation of computerized systems (GAMP5 environment, 21CFR part11)
ERP, GED, automated production systems
Integration, software, unit and non-regression tests

EQUIPMENT QUALIFICATION

Laboratory & production equipment
FAT, SAT, IQ, OQ, PQ
VMP, protocols, reports

OPERATIONAL QUALITY ASSURANCE

Processing Quality Events / NC / CAPA / Change Control
Coordinating quality action plans
Quality management with suppliers, production and laboratories

REGULATORY AFFAIRS

Writing and updating CE/510k marking files
Regulatory monitoring
Provide answers to questions from notified bodies and health authorities
Export submission (worldwide)

RISK MANAGEMENT

AMDEC Methodology (pFMEA) on products and processes
Defining the risk management plan and updating/creating the RMF
Benefits/risks documents

DESIGN TRANSFER

Design input, output, verification and documents validation
Writing and updating DMR/DHF/DHR
Management of the exchanges between R&D and production
Methods/industrialization: setting up inspection plans

QUALITY MANAGEMENT SYSTEM

Creating and reviewing the QMS according to ISO 13485 (current version)
Preparing audits and managing post-audit answers
Training, awareness, and supporting staff in the quality process

SYSTEM ENGINEERING

Management of electromedical systems (specifications, test plan, tests)
V&V according IEC 62304, 60601 norms
Writing technical and functional specifications, CDC, URS

AUDIT & CONSULTING

Quality and regulatory audit
Support the implementation of actions plan
Change management support

MEDICAL DEVICES REGULATION

Monitoring customer sites to ensure their compliances with new regulations
PMS, UDI, clinic, reclassification of medical devices
Change control management, implementation of changes

CLINICAL & BIOLOGICAL EVALUATION

Writing clinical and biological evaluation reports
Data recovery (clinical studies or in vivo and in vitro trials data), bibliographic research
Compliance with MEDDEV 2.7.1 rev4 and MDR

SPECIAL PROCESS VALIDATION

Cleaning, conditioning of MDs, sterilization (ETO, gamma, autoclaves), laser marking and engraving, etc.
Strategies, worst cases and sampling plans definition
Trials management with subcontractors

VALIDATION OF COMPUTERIZED SYSTEMS

Validation of computerized systems (GAMP5 environment, 21CFR part11)
ERP, GED, automated production systems
Integration, software, unit and non-regression tests

EQUIPMENT QUALIFICATION

Laboratory & production equipment
FAT, SAT, IQ, OQ, PQ
VMP, protocols, reports

OPERATIONAL QUALITY ASSURANCE

Processing Quality Events / NC / CAPA / Change Control
Coordinating quality action plans
Quality management with suppliers, production and laboratories

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