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 GMP 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

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, and patient safety.
Our competences cover the following fields:

  • Computer System Validation
  • Validation of equipment, utilities, HVAC and instruments
  • Commissioning & Qualification
  • Instruments calibration

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.

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REGULATORY AFFAIRS

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Preparation is the key

Drug products, medical devices, cosmetics and food supplement: we assist your company in all the regulatory procedures with reliability and efficiency.

A team of qualified regulatory affairs consultants is at your disposal to manage all the product lifecycle needs from pre-clinical through post marketing and to cover temporary shortages of staff.
Our services include:

  • Regulatory submission management
  • Evaluation of technical data (chemistry/manufacturing, preclinical, clinical), to help determine the appropriate regulatory procedure – National, Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP), Centralised Procedure (CP)
  • Preparation and maintenance of Regulatory Dossiers
  • Country specific planning
  • Regulatory start up activities for the preparation and submission procedures for our CRO clinical studies.
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GMP COMPLIANCE

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The culture of quality

QA&QC, maintenance and engineering services to provide appropriate technical support in the management of GMP regulations, with a fundamental commitment to quality.

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

  • deviations and change control management
  • CAPA planning and execution
  • batch record reviews
  • annual product quality reviews
  • complaints management
  • quality risk assessment
  • interim quality management
  • GMP audits as well as GMP Software Solutions

We support in the implementation of appropriate quality systems, including policies and SOPs, to build the framework of your quality program.
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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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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