NETPHARMALAB CONSULTING SERVICES

Netpharmalab Consulting Services is a specialized pharmaceutical contract testing organization (CRO) based in Spain, operating as a subsidiary of AGQ Labs Group, a multinational analytical services company. Founded in 2017 with the specific mission of serving the pharmaceutical sector, Netpharmalab provides a comprehensive portfolio of analytical testing, pharmaceutical development, and regulatory consulting services. The company operates in full compliance with the most demanding international quality frameworks, including Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and FDA requirements, making it a reliable partner for pharmaceutical manufacturers navigating complex regulatory landscapes across European and global markets.

The company's core testing capabilities span both physicochemical and microbiological analysis, delivered from more than 500 square meters of laboratory space divided into fully independent, purpose-designed analytical areas. Physicochemical analysis is supported by a modern instrument suite that includes high-performance liquid chromatography (HPLC), ultraviolet-visible (UV) spectrophotometry, infrared (IR) spectroscopy, and Karl Fischer titration for water content determination. Microbiological services cover comprehensive sterility testing, bioburden determination, microbial limits testing, and other integral microbiological quality control functions — all adapted to client specifications and individual product requirements.

Extractables and Leachables (E&L) studies represent one of Netpharmalab's distinguishing technical specialisms. These studies evaluate the potential release of organic and inorganic compounds from primary packaging materials, drug delivery systems, medical devices, and manufacturing contact materials into pharmaceutical products, cosmetics, and food-contact materials. Using high-resolution chromatography, mass spectrometry, and thermal analysis techniques, the laboratory detects and quantifies substances at trace concentrations, supporting compliance with ICH Q3E guidelines and applicable regulatory submissions. Clients receive full E&L programs encompassing extraction simulation, controlled extraction studies, and toxicological risk assessment support for identified compounds.

Nitrosamines analysis is another area of significant technical depth at Netpharmalab. In response to the global regulatory focus on nitrosamine impurities in pharmaceuticals driven by the EMA, FDA, and other health authorities, the laboratory has developed validated methods using both liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) and gas chromatography coupled to mass spectrometry (GC-MS) to detect and quantify nitrosamines and mutagenic impurities at parts-per-billion (ppb) concentration levels. The LC-MS/MS platform — including a Shimadzu triple quadrupole 8050 with APCI ionization — achieves limits of detection (LOD) down to 0.1 ppb and limits of quantification (LOQ) of 0.2 ppb, meeting stringent acceptable intake limits established by regulatory agencies for genotoxic N-nitrosamine compounds.

Galenic development (desarrollo galénico) — the science of formulating active pharmaceutical ingredients into stable, efficacious, and manufacturable dosage forms — is a core pillar of Netpharmalab's service portfolio. The laboratory develops a range of pharmaceutical dosage forms including solid oral forms, liquid preparations, and specialized formats, each tailored to client specifications and target patient populations. This development work is complemented by robust analytical method development and validation, ensuring that new formulations are supported by validated, regulatory-ready quality control procedures from the outset of the development program.

Stability and storage studies are conducted in the company's own climatic chambers, maintained at controlled temperature and humidity conditions aligned with ICH Q1A(R2) guidelines for pharmaceutical product stability testing. These programs support registration dossiers, shelf-life determination, and ongoing post-approval stability commitments for both new and existing marketed products. The ability to conduct GMP-compliant stability studies in-house allows Netpharmalab to offer clients a vertically integrated path from formulation development through the generation of stability data packages required by regulatory authorities worldwide.

Netpharmalab's consulting services extend the company's scientific expertise directly into client facilities as well as its own laboratories. Analytical consulting (consultoría analítica) covers bibliographic search and state-of-the-art reviews, development of new analytical methods using advanced instrumentation, inter-laboratory analytical transfers, method validation and co-validation exercises, and root-cause investigation for out-of-specification (OOS) results. Galenic consulting similarly provides expert support for formulation troubleshooting, reformulation initiatives, and resolving dissolution challenges — an area the company has identified as a critical and often underestimated barrier behind otherwise successful pharmaceutical reformulation projects.

Following the acquisition and full integration of Docuchem — a pharmaceutical laboratory founded in 2006 at the Girona Science and Technology Park (Parc Científic i Tecnològic de Girona) with approximately 35 specialist professionals — Netpharmalab now operates from two coordinated Spanish laboratory sites in Madrid and Girona. Docuchem contributed deep expertise in QC/QP batch release, analytical development for both conventional small-molecule medicines and biological drugs, and established nitrosamines capabilities. The combined entity serves pharmaceutical manufacturers, generic drug developers, cosmetics companies, medical device producers, and food-contact material suppliers nationally and internationally, underpinned by the resources, global network, and multisector analytical infrastructure of the AGQ Labs Group.