QPLab - Pharma Services, Lda

QPLab - Pharma Services, Lda

About

Company description

QPLab is a private entity that initiated activity in 2018 with end-to-end services for the Pharmaceutical industry to approve and release products in the EU: Analytical services, Qualified Person support and Consultancy services (GMP/GDP and GACP). 

The team includes professionals with over 20 years of experience in the Pharmaceutical and Biopharmaceutical Industry (steriles and non-steriles) in areas of Quality Control, Manufacturing, Development, Validation, Quality Assurance, Qualified Person activities etc.. The team also includes expertise in the area of Medicinal Cannabis (GACP)

Analytical Development and Validation
- Transfer of Analytical Methods
- Process Validation 
- Analytical Methods Optimization
- Validation of Analytical Methods 
- Identification and Assay of Preservatives and Other Components
- Related Substances Analysis
- Dissolution Tests
- Stability indicator assay analytical methods
- Cleaning Validation Analytical Methods
- Cleaning Validation Recovery Studies (swab and rinse)
- Identification and Assay of API
- Stress Studies

Analytical Services
- Identification and Assay of API
- Identification and Assay of Preservatives and Other Components
- Related Substances
- Dissolution Tests / Quantification by HPLC and UV
- Disintegration
- Hardness
- Friability
- Uniformity of Mass
- Stability Studies Analysis
- Routine batch Testing
- Support to Analytical Deviations and Complaints

QP Batch Release- Batch Testing according to the client CoA
- Managing Quality Agreement
- Warehousing QP
- Managing deviations, change controls 
- Batch release in according with the Market Authorization
- CoA Emission

Quick facts

Sales markets Western Europe; Eastern Europe
Affiliated categories: Analytical Development |Chromatography |Development & Validation of Analytical Methods More

QPLab - Pharma Services, Lda

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