Pharma-Consultants-Pharmacovigilance

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PHARMA CONSULTING

Pharma-Consultants-Pharmacovigilance

SEE THEM
IN ACTION

PHARMA CONSULTING

Pharma 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 training & recruiting.

VALIDATION

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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.

Our multidisciplinary team will assist you in validation strategies optimization, providing an effective validation life cycle and master plan (VMP). 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

Our Software team is also at your service to develop customized software systems to help manage your critical instruments calibrations and reference samples, from simple timetables to complex management systems.

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.

We offer a wide range of compliance and quality assurance services:

  • Quality System Design and Compliance Evaluation
  • Mock Inspections and Assistance During Inspections/Post-Inspection
  • GAP analysis & Risk Assessment of existing systems
  • Remediation Plan for EU&US GMP

Our area of expertise also includes compliance support for engineering services, such as:

  • review and optimization of maintenance process
  • analysis of current system
  • development of action plans
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GCP-Good-Clinical-Practice-certification-ICH

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

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.

TRAINING & RECRUITING

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Focus on people is the basis for HR

An HR Department that offers training and recruiting services to pharmaceutical companies willing to invest on people.

Thanks to a wide experience in the pharmaceutical sector and a network of internal senior profiles, focused on the main topics of the pharma world, legislations updating and best practices, our HR Department offers top quality training programmes.

JSB Solutions also provides an active recruiting service available for external pharmaceutical companies for a complete support in new talents research. Attention to people and fulfilment of client’s requirements are the keys to achieve the best solution for HR empowerment.

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eCTD-IMPD-CMC-Marketing-authorisation