Regulatory quality grounded in documents, records and evidence

Intelilab is a consultancy focused on setting up and reviewing Quality Systems, regulatory assessments, inspection readiness, validation, governance and technical support with infraction notices. We work with companies of different sizes, mainly with operations related to medicines and medical devices.

Talk to Intelilab

How we understand regulatory quality

A procedure describes how the process should work. The records show how it was carried out.

When we analyze a deviation, for example, we want to be able to identify the problem, the investigation, the decision made, the actions opened and the evidence of closure.

The same principle applies to training, suppliers, storage, transportation, validation and other processes.

How we work

The work starts with defining the scope.

We then select the necessary evidence, analyze documents and records and talk with the people involved in the processes. When planned, we visit the operation.

Findings are recorded with their source and organized by criticality and priority. When a conclusion cannot be supported by the material available, it remains as not verified.

Areas of practice

Intelilab works on projects related to:

  • Assessment and inspection readiness
  • Quality System
  • Validation and Qualification
  • Quality Governance
  • Technical response to infraction notices
  • Distribution and storage
  • Transportation
  • Manufacturers and GMP
  • Medical devices

Team

Fernanda Manfredini

Fernanda Manfredini

Partner · Quality in the pharmaceutical industry

She was Quality Director at a multinational pharmaceutical company, responsible for the Quality System in 4 Latin American countries. Over 16 years in the industry, she hosted inspections by health authorities and corporate audits, prepared sites for these visits in Brazil and abroad, and prepared action plans and official responses to authorities.

With this experience, Fernanda knows inspection preparation from the perspective of the inspected party: which documents and records the company needs to have organized and where failures tend to appear.

Pharmacist, graduated from Unicamp, with a postgraduate degree in Business Administration from FGV. At Intelilab, she works on assessment and inspection readiness, technical responses to infraction notices, deviation and CAPA investigations, supplier qualification, and the development of procedures and training.

Marco Júlio Araujo

Marco Júlio Araujo

Founder · Change management and adoption

He has 25 years of consulting experience and has worked with Change Management since 2012. He has led change management in mergers, acquisitions and operational reorganizations, and led the adoption of new processes and systems in projects spanning up to 12 countries and more than 3,000 users.

His work starts where implementation ends. He checks whether the team has started working the new way or has quietly gone back to the old process. In a Quality System, that is the difference between an approved procedure and a procedure that is followed.

He has worked in the consumer goods, healthcare, banking, beverage and industrial sectors. He holds the HCMBOK® and HCMP® certifications and specializes in applied Artificial Intelligence. At Intelilab, he leads the implementation of procedures and training, monitors adoption by teams and applies AI to day-to-day quality work.

How we work with clients

We define the scope before starting and record the limitations of the analysis.

We do not treat an unverified item as compliant. We do not fill documentation gaps with assumptions. Nor do we promise inspection approval or a specific outcome in an administrative proceeding.

When a project requires specialized expertise outside Intelilab's scope, this is communicated before the corresponding stage is carried out.

Would you like to discuss a specific problem?

Explain the company's context and what needs to be solved.

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