Biotechnologies

Research & Development

Research projects
Patent filing (IP, filing and PTC application)
Scientific monitoring
Genetic engineering

Pharmaceutical development:
Analytical development
Galenic development/Optimisation of the formula
Stability studies, packaging
Establishment of experimental design (NemrodTM, DesignExpertTM)/Trouble shooting
QBD and risk analysis (AMDEC)
Development of the upstream process
Development of the downstream process

Industrial development:
Implementation and/or optimisation of the manufacturing process
Scaling up
Technological transfer

Quality Control

Optimisation and Validation of analytical methods (including bioburden and endotoxins, …)
Physico-chemical and microbiological controls of PM, IP, PF and packaging items
Implementation of the control methodology
– Sampling strategy (sampling, frequency)
– Conservation of samples
Control and monitoring of product stability (on-going stability)
Management of deviations linked to the laboratory activity
Analysis of anomalies, OOS and OOT and follow-up of investigations
Drawing up protocols and analytical reports
Carrying out inter-laboratory Gap analysis/ methods
Review of the analytical part of the batch dossier
Data integrity
Deployment of the requirements of the specifications: GMP, GLP, ICH, etc.

New works and maintenance

Management of technical affairs
Coordination between the different departments (quality, purchasing, production, finance, etc.)
Project monitoring from the definition of the URS until the commissioning of equipment/ utilities / buildings)
Commissioning/FAT/SAT/QI/QO/QP
Implementation of the maintenance strategy (curative, preventive and ameliorative)

New works & revamping
Design of manufacturing, packaging, cleaning or serialisation lines
Design of utilities and/or buildings
Sizing of bioreactors

Supply Chain

Analysis and monitoring of transport conditions (logistical complaints, temperature excursions, etc.)
Coordination of recalls/ batch withdrawals
Change control and CAPA monitoring at the level of the distribution chain
Establishment/modification of distribution channels
Support for depositaries
Qualification of the suppliers
Monitor the implementation and compliance with BPDG

QHSE Technical Supervision

Extension projects, maintenance, shutdowns
Creation of safety receptions, prevention plan, fire permits and management of the DI system
Verification of the qualification of the participants, the conformity of the equipment
Occupational Risk Assessment
Assistance in setting up and monitoring means of protection (EPI/EPC)
Control of the good practice of the applicable standards and instructions (auditing)
Specific Missions:
– ISO14001:2015, OHAS18001:2007, ISO45001:2018, MASE
– ICPE dossiers, chemical risk assessment, ATEX study

QA system

Implementation and Optimisation of the SMQ
Deployment of normative requirements and GxP, ISO 9001, ICH benchmarks
Identification and mapping of processes
Preparations for inspections (ANSM, FDA) and for internal audits
Document management (Writing of SOP, WI, quality manual …) and implementation of GED
Risk management approach
Training
Audit, gap analysis
AQ Suppliers, supplier audits, subcontractors
Normative and regulatory regulation
Identification and drafting of procedures, work instructions and operating methods
Implementation of management tools (access, Excel, specific software)

Operational QA

Management of deviations, anomalies and non compliance
Technical research
CAPA Management
Change Control Management
Customer Complaints management
Creation of Product Quality Reviews
Environmental monitoring (periodic review of ZACs, etc.)
Intégrité des données
Release of batches
Maintaining sterility:
– risk management of microbiological contamination (microbial and viral)
Assessing risks and impact
Ensuring the microbiological safety of cell banks
Periodical review of trends

Qualification

Qualification and validation: initial, retrospective and periodical
Qualification of Premises and utilities
Equipment qualification (production, packaging, control, laboratory)
Management and validation of the V-cycle:
– Definition of user needs (URS)
– Drafting specifications
– Traceability matrix, risk analyses, Validation Master Plan
– Carrying out tests, and writing reports for the phases of QC, SAT and FAT, QI/QO/QP
– Validation Report and put into production

Validation

Validation of manufacturing processes
– Dry form (mixing, granulation, compression, film coating)
– Liquid form (dissolution, suspension, clarifying filtration, distribution)
– Sterile form (dissolution, sterilisation, distribution, lyophilisation, sterility test)
– Biotechnology (Upstream/downstream Process)
Cleaning validation (manual, semi-automatic, CIP) or sterilisation
Analytical, physicochemical & microbiological method validation
Validation of transport

VSI – VSA

Serialisation – Aggregation
Data Integrity
Automated and computerised systems
Global and local systems
Qualification of infrastructures
Systems involved:
– LIMS: Laboratory systems
– MES: Production systems
– ERP (SAP, SAGE X3,…)
– Software
– Excel/VBA macro files

Consultation and maintenance of dossiers

Pharmaceutical content
– Module 3: writing and updating of pharmaceutical and biological data relating to the active ingredients (3.2.S) and the finished product (3.2.P)
– Variations dossier (IA, IB, II)
– DMF/ASMF
Preclinical and clinical content
– Module 4 : non-clinical data
– Module 5 : efficacy and safety of clinical data
Appendices: RCP, instructions, labelling, packaging
Update of the dossier according to the life cycle of the product (raw materials, manufacturing processes)
Regulatory developments
Answers to questions from regulatory authorities
Drafting of a business opening dossier
Control of labelling information, advertising
Publication of dossiers
Biological Licence Application (BLA) request
Regulation of biosimilars (comparability exercise, etc.)

Registration and Submission

Registration/filing strategy and procedure: National (France), Centralised (EMA), Decentralised, Mutual recognition
Reformatting of dossiers (e-CTD)

Pharmacovigilance

Collection, entry and management of PV data
Drafting of PSUR, DSUR, PGR
Interface with healthcare professionals, authorities and internal partners

Implementation of clinical studies

Drafting of key documents
Submission of documents to the relevant authorities
Managing amendments
Development of clinical trial protocols
Clinical research
Data Management
Biostatistics
Managing the clinical project
Coordination of clinical trials

Selection and monitoring of CRO

Benchmarking of a pre-defined panel
Logistics of research centres

Post Market Surveillance

Drafting of PSUR, PBRER and clinical overview
Pharmacovigilance
Signal reports
Reconciliation
Presentation of results and summaries to the evaluation committee