health and life sciences solutions

benchmark innovation and solutions at the service of your company

Real time innovation and production

The pandemic highlighted the need for agility and innovation capacity in the pharmaceutical, medical devices and PPE industries. Real-time innovation and production are the new challenges in a demanding and rigorous regulatory context. ISQ provides comprehensive and innovative solutions that address these challenges and contribute to agility and competitiveness in the sector.

Health and life sciences solutions

We develop customised solutions for the different sub-sectors of Life Sciences, for pharmaceutical and scientific laboratories, medical cannabis and medical devices. We run dedicated laboratories for the quality control of pharmaceutical products, stability studies and quality control

We develop tailor-made solutions for pharmaceutical and scientific laboratories, ranging from the design to commissioning and validation of facilities and equipment, GMP compliance, development of analytical methods and training, or even outsourcing of laboratory management.

  • Assessment of needs, regulations and standards
  • Due diligence
  • USR Definition
  • Laboratory, Health and Safety Project
  • Review of the Construction and Supervision and Inspection project
  • Project management
  • Procurement support
  • Commissioning and Functional Testing, Safety Check
  • Qualification and Validation
  • Quality management systems
  • GMP compliance support
  • ACCREDITATION EN ISO / IEC 17025
  • Audits and inspections
  • ComputerIzed Systems Validation
  • Data integrity
  • QA/ QC
  • Equipment calibration planning
  • Regulatory and periodic inspections
  • We have a Laboratory entirely dedicated to the quality control of pharmaceutical products: QCPharma with INFARMED (European Medicines Agency Recognition) authorisation and audited by FDA (American Food & Drug Agency).
  • Through its affiliate Bluestabil, ISQ offers one of the few storage services in Portugal for drug stability and stability studies worldwide.

We develop and implement Medicinal Cannabis projects with regard to Due Diligence (environmental, structures, etc.), Manufacturing and Laboratory Design, GMP compliance (e.g.: technical assistance and validation of equipment for pharmaceutical grade), CSV – Computerized Systems Validation and Data Integrity, Quality Assurance / Quality Control, etc.

Conformity Assessment and Tests of Medical Devices (MD) and Personal Protective Equipment (PPE), specifically surgical masks, ventilators and Covid-19 monitoring and disinfection systems equipment.

  • Calibration of equipment and measuring systems
  • Accredited laboratories and certified technicians, recognised as Notified Bodies and accredited as Sector Inspection Bodies

Molecular biology laboratory for the detection, quantification and variant identification of SARS-CoV-2 in wastewater, air and surfaces, with results in 24 hours

complete solutions for health and life sciences

Experience, know-how, resources and recognition

ISQ in Health and Life Sciences

With extensive experience in the sector, ISQ not only carries out inspection, testing, calibration, consultancy and training activities, but also has specialised laboratories and runs joint R&D+i projects with partners in the sector.

With all of our activities combined, we have been contributing to the development of this industry for decades.

Medical workers doing analysis in laboratory during corona virus outbreak
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QFA – the Chemical, Pharmaceutical and Agrifood Unit

ISQ decided to bring together its pre-existing analysis and testing skills in the chemical, pharmaceutical and agrifood sectors and created a highly specialised unit known as QFA (Chemical, Pharmaceutical and Agrifood), dedicated to providing analysis services to several sectors of activity.

These are areas of activity with high technological and scientific components, based on the laboratory activity experience built up by the ISQ Group.

In terms of pharmaceutical product quality verification, with Infarmed and FDA authorisation, QFA controls the physical-chemical quality of drugs for human use, experimental drugs and active substances. This control also includes dosage analysis, the analysis of equivalent substances and uniformity of content of pharmaceutical products for compliance assessments, as well as the assessment of any impurities that may be present, such as nitrosamines (chemical agents that are carcinogenic to humans).

QCPharma – laboratory specialising in drug analysis method development and validation

Specialists in quality control, stability testing, proof of cleaning processes and forced degradation studies, as well as the development and validation of analytical methods tailored to the needs of our partners/customers.

QCPharma celebrates first year of activity

QCPharma was inspected by the FDA in February 2020 and received a letter of acceptance from the FDA regarding its services. It holds a GMP authorisation from the National Regulatory Authority (Infarmed) for quality control tests on drugs, experimental drugs, active substances, narcotics and psychotropic substances for human use (Tables I to IV of Decree-Law no. 15/93 of 22 January). It is also frequently audited by partners / customers. It offers confidence and guarantees results.

In addition to GMP environment services, it also carries out activities in non-GMP environments. It therefore ensures a proper transition from the project development phase to the validation and marketing phases.

  • Development and validation of analytical methods
  • Transfer of analytical methods
  • Validation of cleaning methods
  • Quality and stability control activities
  • Finished product (oral, parenteral and inhalable)
  • Products in development
  • APIs (including controlled substances)
  • Raw materials
  • Excipients
  • Medical cannabis (under approval)
  • High performance liquid chromatography coupled to triple quadrupole mass spectrometry (LC-MS/MS)
  • Gas chromatography (GC -FID and HS-GC/FID)
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • Atomic Absorption Spectrometry (flame, hydride generator and graphite chamber)
  • Ion chromatography
  • Dissolution (UV-VIS and HPLC)
  • Potentiometer
  • Karl-Fisher
  • Viscometer
  • Density meter
  • Tablet disintegrator
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3S Bluestabil – Stability Studies Services

Provision of services in the area of stability studies, specifically storage under controlled environmental conditions, thereby guaranteeing product safety and traceability.

3S Bluestabil was founded in September 2013 and authorised by Infarmed in March 2014. This company is the result of a partnership between the ISQ Group and Aralab, a climate solutions specialist. Its core business consists of providing space to place medicines in environmental chambers and providing stability services for pharmaceutical products. 

Dedicated laboratory for SARS-COV2 tests with 24-hour results

The Labiagro Molecular Biology Laboratory, an ISQ group company, has been working on the detection and quantification of SARS-CoV-2 in wastewater, air and surfaces. It was able to create an alert system that can communicate with stakeholder entities which, after verifying an increase in the amount of virus in a community, are able to take action to prevent a new wave.

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The detection of the virus is done by molecular biology techniques, being possible not only to detect the presence of this agent but also to quantify its presence. Given this possibility of the methodology, it is possible to create an alert system, capable of communicating with the interested entities that, by verifying an increase in the amount of viruses in a community, can act in the prevention of a new wave of the virus.

In addition to these two possibilities, detection and quantification, it is possible to identify the variants of the virus circulating in a given community.

Labiagro’s Molecular Biology Laboratory has been working on the detection and quantification of SARS-CoV-2 in wastewater, as well as on the research of this virus in other equally important matrices, such as air samples or surfaces.

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With the new molecular biology laboratory, Labiagro presents integrated solutions and is able to provide services to competent authorities, health entities and industry from various sectors of activity (agri-food and others).

The laboratory has a wide range of technological equipment capable of detecting molecular biology techniques – PCR – the etiological agent SARS-CoV-2, and the result, if requested, can be given within 24 hours

The Solutions Specialist is an expert in the market where your business operates, with an integrated view of our services and skills and how they can help you achieve better results.

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