pharmaceutical industry
technical department
engineering
equipment, processes and utilities
From user requirements to qualification, production and operations
Engineering study of the phases of Concept Engineering – Basic Engineering – Detail Engineering :
- Procedures
- Mechanical engineering
- Electiricty / Automation (GAMP5) / Intrumentation
- HVAC
Commissioning :
- Installation monitoring
- Implementation of protocols
- Troubleshooting
Production support and continuous improvement
development
formulation / manufacturing process
From the development of the active ingredient to the pharmaceutical product for clinical or commercial phases
- Formulation or pharmaceutical production
- Transfert :
- Industrialisation and scale-up: from the lab or pilot to the commercial phase
- Outsourcing to a CMO, etc
- Support/expertise in validation, optimisation of processes
qualification / validation
equipment, processes and utilities
- Qualification of equipment or utilities :
- Risk analysis (FMECA)
- Drafting the protocols DQ/IQ/OQ/PQ
- Implementing protocols
- Drafting reports
- Validating processes
- Validating cleaning and sterilisation (CIP/SIP/COP)
- Computerized system validation (CSV)
quality department
Quality support for R&D or production
- Quality Management System
- Quality Assurance (QA) :
- Operational QA: CAPA, deviation, change control, review of batch records, investigations, etc.
- Supplier AQ
- Compliance
- Review and approval of protocols for qualification and validationRevue et approbation de protocoles pour la qualification et la validation
- Quality Control (QC) :
- Development / Validation / Transfer of analytical methods
- Stability tracking and trends
- Qualification of laboratory equipment
Standards environment : GMP, GDP, GLP, ICH standards
regulatory affairs department
- Regulatory strategy for all healthcare products and regulatory requirements adapted to each country
- Drafting marketing authorisation applications in the CTD / eCTD formats (Modules 1 to 5) for national procedures, centralised procedures (CP), decentralised procedures (DCP) or mutual recognition procedures (MRP)
- Submitting the applications, monitoring the registration process and responding to questions asked by the health authorities
- Regulatory maintenance (updating of module 3, variations, renewals, transfers, implantable medical devices, “Etablissement Pharmaceutique Exploitant” license applications used for opening a pharmaceutical company engaging in commercial activities in France)
- Support and drafting of CEP / ASMF (Certificates of Suitability / Active Substance Master Files)
- Validation of packaging, labelling and artworks (translation of summaries of product characteristics and leaflets, etc.)
- Drafting and checking of promotional materials
- Market strategy / access and registration (CE marking) of medical devices
- Regulatory support for clinical trials
- Regulatory monitoring
project department
- Management of engineering projects: new projects or revamping
- Infrastructure & buildings
- Utilities (purified water, water for injection, steam, etc.)
- Equipment (formulation, filling, packaging, including serialisation-aggregation)
- Worksite phase: technical coordination and monitoring of implementation
- R&D project management: development of processes and formulation
- Scheduling - Cost control - Project purchases
- Health, Safety and Environment (HSE): monitoring of works, management of professional risks
- Management of quality projects: audit preparation, upgrading of quality systems
clinical and vigilance operations
clinical operations
Altogen helps its clients manage and run their clinical studies, by supplying staff in the following areas :
- Clinical Trial Assistants (CTA)
- Clinical Research Associates (CRA)
- Local/Global Clinical Trial Managers (LTM/GTM)
vigilance
We support our partners in pharmacovigilance, cosmetovigilance, medical device vigilance and nutritional vigilance in the detection of signals and the explanation and prevention of adverse incidents.
For this purpose, our employees work in areas such as MedDRA coding, entering cases into databases, processing adverse incidents and drafting periodical reports (PSUR/DSUR) for our clients.
We are hiring :
For this purpose, our employees work in areas such as MedDRA coding, entering cases into databases, processing adverse incidents and drafting periodical reports (PSUR/DSUR) for our clients.
We are hiring :
- database managers (SafetyEasy, ArisG, Argus)
- pharmacists
