Service Overview

A multi-disciplinary team of qualified regulatory affairs consultants is at your disposal for all aspects of your clinical trial applications and marketing authorization applications for human medicinal products.

At the pre-registration phase

we support your scientific advice requests, prepare and review Investigational Medicinal Product Dossiers and Investigator Brochures, and provide advice on regulatory submission strategy. Our consultancy includes advice on informed consent applications and bibliographic submissions and covers numerous product types:

  • Orphan drug
  • Biologicals
  • Biotech products and advanced therapies
  • Biosimilars
  • Generics
  • NCE’s

Wide spread

If you are aiming to market your product in Europe, G.I.T.O will closely collaborate with your team, and develop a tailor-made regulatory strategy for your product and guide you through the different procedural hurdles and authority interactions.

clinical trial

With strong expertise in the preparation and review of clinical trial applications, G.I.T.O guides you through your clinical trial applications in Europe, Canada and US, using our regulatory knowledge database (drug import regulations and procedures) of over 50 countries.

Post-registration

G.I.T.O’s Regulatory Affairs will support the maintenance and Life Cycle Management of your products, with support to your variations, line extensions, renewals, PSUR submissions and responses to Authority requests.

Why Choose GITO Consulting

  • G.I.T.O is synonymous with the highest levels of integrity, impartiality and accuracy.
  • We have been involved in the design, manufacture and monitoring of mechanical sampling systems (MSS) for over 25 years
  • our bulk cargo systems are in operation in over 20 countries
  • G.I.T.O provides expert consulting services for the design, manufacture and support of your mechanical sampling system.
  • Our mechanical sampling consulting team works with you from concept definition to full system operation. Based on your needs
  • we develop the project specifications, review them with your team and then design the system.
  • We have earned a reputation for reliability - chutes and material flow systems .Fabrication, installation, commissioning and ongoing mechanical sampling support are also available from G.I.T.O.

The G.I.T.O team considers your specific needs, potential capital and operational costs to ensure that your bulk cargo mechanical sampling system meets your budget and delivers best value and optimal performance. Their findings allow you to optimize your system, based on your budget, needs and other constraints.
Contact G.I.T.O today to discover how we can help with your pre- and post-registration regulatory requirements.