QCPharma – laboratory for the pharmaceutical industry

The perfect partner for the Pharmaceutical Industry.
drugs

QCPharma – a laboratory specialising in the pharmaceutical industry.

logo QCPharma 4d edited
QCPharma – laboratory for the pharmaceutical industry 1

We are 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.

Quality and Partnerships are key elements in everything we do

QCPharma was inspected by the FDA in February 2020 and received a pre-approval letter of acceptance from the FDA regarding our services.

We hold a manufacturer’s authorisation and GMP certificate from the National Regulatory Authority (Infarmed) for quality control tests on drugs, experimental drugs, active substances, narcotics and psychotropic substances for human use:

Medicinal products for human use, experimental medicines, active substances.

GMP Certificates:

  • GMP Certificate (Medicinal Products for Human use);
  • GMP Certificate (Experimental Medicines);
  • GMP Certificate (Active Substances);

and Manufacturing Authorization Issued by Infarmed – National Authority for Drugs and Health Products, I.P.

 Narcotic, psychotropic substances and preparations included in Tables I to IV of Decree-Law 15/93 of 22 January
  • INFARMED Order of 2018-09-19 authorizing the manufacture of narcotic drugs and psychotropic substances, included in tables I to IV attached to Decree-Law no. 15/93, of 22 January. Published in Diário da República, on 22/02/2019, the Notice No. 2954/2019.
  • (Tables I to IV of Decree-Law no. 15/93 of 22 January) and for medical cannabis (in progress).

We are also frequently audited by partners / customers. We offer confidence and guarantee results.

In addition to GMP environment services, we also carry out activities in development environment. We ensure a proper transition from project development phase to validation and marketing phases.

Robustness, reliability and high analytical performance capacity combined with a customer / partner focus are integral parts of our DNA.

Analytical services

  • 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 implementation)
  • Stability studies


Analytical techniques

  • High performance liquid chromatography coupled to triple quadrupole mass spectrometry (LC-MS/MS)
  • High performance liquid chromatography (HPLC and UPHLC)
  • Gas chromatography (GC –FID and HS-GC/FID)
  • Gas chromatography coupled to mass spectrometry (GC-MS and HSGC/MS)
  • 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

Why QCPharma?

  • Complete Portfolio / One-stop-shop laboratory – providing support to the Pharmaceutical Industry, from quality control operations and stability tests to cGMP consulting and training services.
  • Customer Service – Ability to meet the highest industry standards and requirements. Flexibility, precision and credibility. Continuous adaptation to customer and market needs.
  • Partnerships and Consultancy – We establish solid relationships with relevant partners, provide advice and assistance based on our experience with our customers’ decision-making processes and offer partnerships for the implementation, development and validation of methods.
  • Scale, synergies and a national and international presence – we form part of the ISQ GROUP, a national and international benchmark entity which since the 80s has been diversifying its activities into business sectors such as the environment, safety, metrology, and inspections of facilities and electrical and construction equipment, as well as safety tests on goods and equipment. The ISQ Group has always upheld Innovation, Quality and Safety as common denominators.

Contacts

  • Lab Manager
  • Margarida Pinto
  • +351 961560905
  • mlpinto@isq.pt
  • Commercial Focal Point and Operations Planning Responsible
  • Catarina Gonçalves
  • +351 927405637
  • cjgoncalves@isq.pt

Address

  • Main Lab

Taguspark (inside ISQ Campus)
Av. Prof. Dr. Cavaco Silva, 33 Edf. G
2740-120 Oeiras, Portugal

Contact Us