Pharma-Consultants-Pharmacovigilance

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LIFE SCIENCE CONSULTING

Pharma-Consultants-Pharmacovigilance

SEE THEM
IN ACTION

LIFE SCIENCE CONSULTING

Life Science Consulting

Discover our all-round consulting services for pharmaceutical companies

We support life science companies during the whole drug development life cycle. We assist pharma industries in order to work in compliance with GxP regulations and standards, to comply with all the regulatory procedures and to optimize validation strategies. Our wide range of services also includes support in maintenance, engineering and logistics

COMMISSIONING & QUALIFICATION

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A targeted support for your validation strategies in the GxP area

Your closest advisor for CSV, equipment validation, commissioning & qualification and instruments calibration.

Assisting you in all validation and optimization strategies, validation life cycle and master plan (VMP) is the mission of JSB’s multidisciplinary team. We will support you in tests and protocols management & implementation, or relevant SOPs to guarantee the quality of your processes, products.
Our competences cover the following fields:

  • Computer System Validation & Data Integrity Compliance
  • Commissioning & Qualification
  • Clean Room Qualification
  • Cleaning Validation
  • Temperature mapping services
  • Calibration services
  • GAP Analysis
  • Risk assessment

GxP COMPLIANCE

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The culture of quality

A company in your company: we are able to support with consultants or working group to manage compex projects.

Our Quality Assurance team is able to support you during the various stages of the quality process, from project management and training, to support and results. JSB offers its support for identifying the most suitable control procedures for the quality management of the client company.
The team will work closely to set up a quality assurance and control plan, which keeps systems up to date with the latest regulations, GMP and GCP, and industry standards

Our range of services:

  • Remediation plan for EU&US GMP
  • Batch record review and PQR editing
  • GAP analysis & risk assessment of existing systems
  • Change Management, Non-conformity and CAPA
  • Support during Inspection and Customer/Third Party Audits
  • Support to readiness
  • Internal and supplier audits (System Audits)
  • Document/Module Life Cycle Management and GxP Quality Systems SOPs
  • Assistance during inspections
  • GxP quality system design and compliance evaluation
  • Design, implementation and maintenance of SGQ according to ISO 9001:2015 and ISO 14155:2012 and ISO 13485
  • GMP Software Solutions

Our area of expertise also includes the clinical area:

  • GCP Documentation Lifecycle Management
  • Validation support for IT data collection systems (eCRF)
  • Drafting and revision of study papers
  • Quality Check Trial Master Study File
  • Role of QA Manager by DM 15.11.2011
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GCP-Good-Clinical-Practice-certification-ICH

MAINTENANCE & ENGINEERING

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Setting up and operating production facilities

Through our engineering and maintenance services we are able to support our customers in the management of manufacturing facilities for the pharmaceutical industry, in compliance with the regulations in force and ensuring high quality results.

Our areas of expertise include:

  • Revision, optimization and reworking of maintenance processes in compliance with industry regulations
  • Creation of extraordinary work orders to ensure the correct operation of machines and utilities even in emergency conditions
  • Risk assessment through FMEA (Failure Mode and Effect Analysis) analysis of critical components and identification of the best maintenance strategy and critical spare parts
  • Assignments of workloads to different operators based on tasks and workload amount
  • Drafting of technical specifications for Full Service maintenance contracts with identification of the technical scope, performance levels required by the Contractor (SLA) and maintenance performance indicators (KPIs)
  • Drawing up of Work Orders instructions interfacing with maintainers, line operators, suppliers and other consultants
  • Warehouse stock management to ensure proper maintenance flow
  • SOP editorial staff for proper plant maintenance management.

Our team, composed of resources with interdisciplinary skills, characterized by different experiences and backgrounds, is able to support the customer in all areas of reference.

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services-maintenance-engineering-companies-pharma

LOGISTICS

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A support for the entire supply chain

Our logistics team is able to meet the needs of the customer from planning and managing shipments to purchases, with the aim of optimizing the entire supply chain.

We can support you in the following areas:

  • Management of EEC and non-EEC transport
    Production planning and warehouse management
    • Purchases
    • Management of documents
    • Management of suppliers
    • Creation of KPIs
    • Analysis of logistics processes

Thanks to our services we can plan, implement and control the progress of the supply chain flow.

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FUNCTIONAL SERVICE PROVIDER GxP AREA

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A team to meet the immediate or longer term needs of professional roles in companies, in-house or remotely.

We support you in this specific areas:

  • Quality Assurance
  • Quality Control
  • Engineering & Maintenance
  • Automation
  • Logistics
  • Regulatory Affairs
  • Validation
  • Pharmacovigilance

Relying on our FSP (Functional Service Provider) service you can focus on your core activities while our team support you in activities management in the GxP area, in accordance with your processes, systems and expectations.