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CoCEPTIO » Technical & Regulatory Expertise - CoCEPTIO
Technical & Regulatory Expertise
Accueil » Services » Technical & Regulatory Expertise


Consultancy

For specific assignments, CoCEPTIO can complement your own teams. A service entirely tailored to your needs.

Expertise

CoCEPTIO provides tailor-made audits for all industries.
Our teams will support your teams in the field.

CoCEPTIO can respond to specific needs for expertise in areas including:

  • Technical expertise (PED, updating documents etc.…)
  • Regulatory expertise (GMP, PIC/S, FDA etc.)
  • Strategy (drawing up a Site Master Plan, exploring the structure of a project etc.)
  • Management (project management diagnosis etc.)
  • Carrying out risk analyses such as HAZOP, risk assessments (ISO 13849-1 2008, FMEA-AMDEC etc.), cause analyses (Ishikawa etc.), shutdown preparation (lockout, LOTO procedure etc.) etc.

CoCEPTIO also has extensive experience in the design of equipment:

  • Effluent decontamination station, H202 decontamination airlock, autoclave
  • Isolation equipment: Isolator, BSC, Hood, Downflow Booth
  • Bioreactor
  • Incubator
  • Still, osmosis system, GVP etc. for the production of purified utilities
  • Washing machine, filling line, conveyor belt etc.

Formations

CoCEPTIO also runs on-demand training courses, delivering the high value-added information that you need (in project management and risk analysis, for example).

Our experts also take part in conferences organised by professional associations such as Technifutur, A3P and ASPEC.

References Technical & Regulatory Expertise

Chanel
   
Sky Merck Project 2019-2021
   
Alarm Management
   
Zoëtis 2017-2019
   

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