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Consulting

Serving the Biotechnology, Pharmaceutical, Consumer Healthcare, Medical Devices, Homeopathic and Veterinary industries, GxPi is able to provide a range of services to meet your business needs. Our team that is able to deliver you a range of knowledge, experience, expertise and help across the entire drug development, approval, manufacturing and distribution lifecycle. GxPi provides your business with a tailored service that is focussed on addressing specific issues within your business and delivering results, by carefully defining what needs to be done and then supporting you with the completion of identified task we deliver measurable success, not just advice.
Each Consulting Service area is managed by our highly experienced, industry-recognised leaders, all with over 25 years’ experience within the industry. The team can provide you with a great understanding and knowledge of working within the industry sector and with the regulatory authorities. It has a strong track record of helping clients improve their business and comply with the regulatory requirements of such organisations as - FDA, MHRA, HTA, EMEA, WHO and ICH.
All support services are structured to provide you with clear, straightforward, pragmatic advice that enables you to meet your business requirements as efficiently and effectively as possible. Consulting services can be delivered in a range of formats to suit your needs including;

  • Part-time and interim management support,
  • Auditing,
  • Development of quality management systems (QMS),
  • Remediation planning and delivery,
  • Project Management
  • Coaching & mentoring.

GxPi understands that your business will have varying requirements for consulting support in order to meet the needs of a particular project or activity. That is why GxPi will provide you with a flexible service, which is tailored to your exact requirements and delivers your business with the following benefits:

  • Provision of a totally managed service with a single point of contact to co-ordinate all your project activities and assignments
  • Access to the full range of resources within the GxPi team, ensuring the most appropriate people work with your organisation
  • A service delivery methodology that is focussed on knowledge transfer to you and your team
  • Providing you with a service tailored to your requirements, whether for a short-term study or long-term support, and with a minimum of delay
  • Reduce consulting costs by only paying for the time you need, when you need it and offering a ‘consultancy by the hour’ service to provide the most cost-efficient support service
  • Eliminate additional travel costs associated with non-essential visits
  • Help achieve energy conservation through smart use of resources and IT such as our x-docs system which enables remote collaborative work between your business and our team of consultants

The GxPi team is highly skilled and experienced in identifying, communicating, managing and delivering your Good Manufacturing Practice (GMP), Good Automated Manufacturing Practice (GAMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Distribution Practice (GDP) requirements.

Our service – managed deliverables not contractor placement
Our customers use our contract services because we are focussed on what you need – to deliver a quality service against a defined budget and timescale. We provide you with a fully-managed service that minimises your time spent managing contract support. Benefits we offer you include the option to use specific members of our team to complete specific tasks based upon skill-sets and experience.
GxPi has established an enviable reputation for delivery of contract services based upon trust, professionalism and value. This is supported by our long-term and repeat business with practically all customers the company has ever worked with.

Services

Computer Compliance

Validation and compliance to define, prove and maintain your regulatory requirements

Regulatory and QP

Enabling dossier submission and regulatory approval and release of investigative and marketed products world-wide

Clinical Technology

Utilising expertise and experience to deliver the best selection, integration and use of e-clinical technology solutions for your business

Validation

Smart, cost-effective and resource efficient validation to demonstrate regulatory compliance

Biopharma Process

Providing you with a wealth of experience and knowledge to help get your biopharma products and processes developed, validated, approved and to market

Training

Classroom training and E-lesson packages