Our specialization

  • soluciones para empresas

Specialists in high-demand GMP environments

Our main activity is focused on the manufacture of sterile medicines by aseptic process, one of the most critical environments from a regulatory, technical and operational point of view.

We work with criteria aligned with EU GMP (Annex 1), FDA and PIC/S, applying risk management, practical knowledge of the process and direct experience in plant operation and management.

A valid approach beyond sterile medicines

Expertise in aseptic processes allows us to add value not only to manufacturers of sterile medicines, but also to organisations in other regulated sectors and companies that wish to work or integrate into this environment.

We apply robust GMP principles in a proportionate manner, tailored to each organization's context, actual risk, and maturity level.

SERVICES

Compliance, operability, and business-oriented services

We put our more than 35 years of experience at your disposal to help improve your company through continuous improvement, the improvement of your operations and processes, and your people.

We have extensive experience in the management of operations in the chemical-pharmaceutical sector, which also allows us to advise you on the design of facilities and solutions so that they comply with GxPs, without forgetting sustainability, ergonomics and viability.

In addition, we are specialized in the preparation of sterile products, where we can advise you, propose improvement plans, assist you in the preparation of audits by health authorities and implement the resulting corrective and preventive actions.

aseptic consultoria
calidad consultoria
proyectos consultoria

Who do we help?

Regulated Manufacturers

  • Pharmaceutical laboratories
  • CDMOs
  • New or Operating Sterile Facilities
  • Plants with recurrent deviations or regulatory pressure

Companies in other regulated sectors

  • Companies with GMP or other quality systems
  • Organizations with small structures without a quality system or quality manager
  • Companies that need to reorganize with criteria and risk prioritization

Companies that want to serve the pharmaceutical sector

  • Suppliers of products, services or equipment
  • Engineering
  • Companies in the phase of access to the pharmaceutical market
  • Startups that need to understand real GMP expectations

why us?

Our team combines GMP consulting with experience in sterile drug manufacturing plant management, which allows us to understand both the regulatory expectations and the actual constraints of organizations.

At tri-consulting, we have over 35 years of experience in highly regulated sectors and we make sure to stay up to date with the latest regulations and standards, as well as industry best practices.

This combination of experience and constant renewal and review allows us to offer customized solutions tailored to the specific needs of each client.

We accompany you every step of the way to ensure long-lasting results and effective solutions. Discover success through our 5-step consulting methodology:

At Tri-Consulting we approach each project with a focus on achieving a specific objective, effectively managing time and resources. Our key to success is to maintain the balance between quality, cost and time, thus ensuring that we meet the client's objectives according to their needs.

We are characterized by clear and objective communication with all parties involved. We identify and define deliverables accurately, act quickly to avoid delays and monitor times and costs to ensure an efficient and continuous workflow.

Contact

Do you need technical support to comply with GMP, improve your quality system, or prepare to serve the pharmaceutical industry?

Schedule a Technical Meeting