Empowering research institutes and commercial enterprises across Sweden and the wider European economic zone with certified botanical quantification, stability profiling, and method design.
Sweden’s biopharma and nutraceutical ecosystem, anchored by Medicon Valley, Uppsala's life-science cluster, and Karolinska-adjacent research hubs, maintains exceptional standards for botanical authentication, purity screening, and quantitative analytical robustness.
Scandinavian consumers and Swedish regulatory authorities (Läkemedelsverket / Livsmedelsverket) mandate verifiable evidence against pesticide drift, residual solvent contaminants, and synthetic adulterants in natural bioactive matrices.
Method validation is conducted strictly under ICH Q2(R1/R2) and European Pharmacopoeia (Ph. Eur.) guidelines, ensuring complete audit readiness for submission to the European Medicines Agency (EMA) and Swedish regulators.
Swedish life science procurers require ODM partners capable of bridging early-stage analytical scouting with large-scale commercial validation, eliminating method transfer bottlenecks between laboratory and pilot manufacture.
Delivering multi-dimensional chromatographic and mass spectrometry platforms designed to overcome the intrinsic chemical variability of complex multi-component natural products.
Untargeted metabolomics utilizing UHPLC-QTOF-MS to isolate active chromophores, flavonoids, terpenes, and alkaloid complexes, distinguishing active fractions from matrix interferences.
Systematic screening of stationary phases (C18, HILIC, Phenyl-Hexyl) alongside mobile phase buffers to achieve baseline resolution (Rs > 1.5) and symmetrical peak shape under high-throughput conditions.
Evaluating specificity, linearity (R² > 0.999), limits of detection (LOD) and quantification (LOQ), intermediate precision, repeatability, and robustness against minor pH and temperature shifts.
Compilation of complete analytical dossiers compliant with CTD Module 3 (Quality), accompanied by analytical validation reports (AVR) ready for inspection by European regulatory entities.
Biotechnology firms in Stockholm, Gothenburg, and Lund frequently confront difficulties when scaling up natural raw materials sourced from international supply chains. Discrepancies in secondary metabolites across seasonal harvests cause formulation batch failures.
Our ODM analysis method establishment program delivers standardized, cross-validated analytical blueprints that ensure raw materials sourced globally meet identical chemical fingerprinted parameters when arriving in Scandinavian facilities.
Aligning high-precision contract research with the legal and operational standards of the Swedish and broader EU commercial territories.
Strict mutual non-disclosure guarantees that proprietary formulations, active compound discoveries, and technical parameters remain the absolute property of the entrusting client.
Application of advanced High-Performance Thin-Layer Chromatography (HPTLC) and HPLC multi-wavelength fingerprinting aligned with European pharmacopoeia requirements for complex botanical mixtures.
Climate chamber stability assays (accelerated and long-term according to Zone II storage criteria) providing empirical shelf-life data suitable for Nordic climate distributions.
Direct answers for procurement heads, quality directors, and chief scientific officers serving the Swedish market.
Commercial pharmacopoeial monographs often lack specific separation parameters for enriched botanical extracts or novel proprietary fractions. Custom method development guarantees that matrix interferences are eliminated and quantified active values correspond to verifiable pharmacological potency.
All method validations strictly follow ICH Q2(R1/R2) validation protocols, examining specificity, linearity, repeatability, intermediate precision, accuracy/recovery, detection limits, and system suitability. Comprehensive reports are fully compatible with EMA, FDA, and Swedish MPA dossier standards.
Yes. We furnish detailed standard operating procedures (SOPs), chromatographic column specifications, system suitability criteria, reference substance sources, and run parallel inter-laboratory comparative testing to ensure seamless execution in your in-house laboratory.
Our infrastructure includes High-Performance Liquid Chromatography (HPLC-DAD/FLD/ELSD), Ultra-High Performance Liquid Chromatography (UHPLC), Gas Chromatography coupled with Mass Spectrometry (GC-MS/MS), High-Performance Thin-Layer Chromatography (HPTLC), and LC-MS/MS platforms.
Complete lifecycle solutions covering screening, method establishment, in vitro/animal trials, clinical development, and pilot-to-commercial ODM manufacturing.
