In full compliance with EU-GMP and USFDA requirements, we help managing analytical services of APIs and FDFs through various applications:


Chromatography: liquid (HPLC, UPLC), ion (IC), thin layer (TLC), size exclusion (SEC) and gas chromatography (GC, including headspace), as well as GC-MS, GC-MS-MS, HPLC-MS and HPLC-MS-MS techniques
Atomic spectrometry: atomic absorption and atomic emission (e. g. ICP-OES)
Identification through molecular spectroscopy: NMR, UV/VIS, IR/NIR and mass spectrometry
Elemental analysis
Residual Solvents Methods by GC-HS
Classical analysis: Volumetry, gravimetry, photometry, chemical characteristics, potentiometry, polarography
Physico-chemical parameters: e. g. viscosity, particle size distribution, surface tension

We offer analytical method development (AMD), analytical method validation (AMV), analytical method transfer (AMT) and batch analysis/release testing in a GMP-analytical facility supporting IND, DMF and ANDA filings:

Method development 
Method verification 
Method validation 
Method transfer 
Batch release testing
We also provide in-depth solutions for the analysis of cytotoxic and highly potent drugs from dedicated laboratories.

Active pharmaceutical ingredients and drug formulations are endangered by N-nitrosamines that occur from cross-contamination. We help identify the presence of nitrosamines in pharmaceutical products, which will help you ensure product safety and compliance as per USFDA and EMEA requirements. Our integrated harmonized method and approach enables the identification of N-nitrosamines:
NDMA: N-nitrosodimethylamine
NDEA: N-nitrosodiethylamine
NMBA: N-nitroso-N-methylamino butyric acid
DIPNA: N-nitrosodiisopropylamine
EIPNA: N-nitrosoethylisopylamine
NDBA: N-nitrosodibutylamine

Our services bolster up your approval process by providing validated methods tailored for APIs and FDFs based on ICHQ3D guidance. 
We ensure that the shortlisted laboratory develops a compliance strategy to successfully implement ICH Q3D. 
Development of elemental impurities through ICP-OES & ICP-MS in accordance with the most updated pharmacopoeia standards
Single method solution for 24 elements screening in APIs/drug products

Providing solutions for GMP separation/purification services
Prepping SFC separation/ purification under GMP environment
Expertise in handling peptide purifications ranging from 100-milligram to 100-gram batches
Feasibility study using small sample to establish suitable conditions for separation/purification

Project outsourced to laboratories having vast experience in handling critical separations
Pharmacopeial method verifications
Chiral HPLC & LC-MS method development for generic drugs
Chiral HPLC/SFC method development for NCEs/APIs/formulated products
Preparative chiral HPLC/SFC method development for milligram to kilogram scale separations
Feasibility studies for batch chromatography and SMB separations, from multi-kilogram to multi-ton scale

Analytical capabilities offering isolation and synthesis of complex impurities for active pharmaceutical ingredients and formulations
Characterization of impurities based on (1H NMR, Mass) structural elucidation
Activities can be outsourced to the laboratories having ample infrastructure for quick isolation
Genotoxic impurities quantification
Dedicated team with a strong analytical capability 

Wide areas of extractable and leachable studies covering packaging materials and drug products under testing.
Covered packaging materials: glass vials, rubber stoppers, PP containers, LDPE containers, HDPE bags, EPDM packaging, gaskets and O-rings
Covered formulations: inhalants, parenterals/injectables, ophthalmics, oral vaccines and topicals
Reliable avantgarde testing equipment: HRMS (LC-Q-TOF) LC-MS/MS GC-HS-MS/MS ICP-MS

If you are looking for a new technology for peptide synthesis and development, take a look at the solutions we offer to meet your diverse needs:
Custom peptide synthesis technologies coupled with feasibility studies, process development, lab validation, analytical development and technology transfer 
Synthesis of peptides with natural and unnatural amino acids up to 20AA
Peptides delivered in lyophilized form
Purification technologies
Analytical technologies
Peptide impurity standards