Contract research services

ExSyn offers a full repertoire of flexible and scalable analytical solutions to support and enhance your analytical development.

  • Customized solutions based on either full-time equivalent (FTE) model or stand-alone projects
  • Weekly project updates via email and conference calls
  • Our regulatory affairs team can assist you at all stages of your product development, for both APIs and complex compounds.
  • Transparent communication to accelerate your regulatory approval pathways
  • Outsourcing projects are managed through shortlisted contract research laboratories. based on our meticulous scrutiny that includes pre-audits 
  • Assurance to meet global regulatory requirements (ICH, USP, EP) 
  • Software compliance as per 21 CFR Part 11  
  • Always ensuring on-time delivery of reports

To meet your analytical needs, please scout through our offerings:

GMP analytical services

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

AMD/AMV development & technology transfer

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.

Nitrosamine screening

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

Elemental Impurities Studies [ICH Q3 D]

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

Preparative purifications 

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

Chiral Applications

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

Impurity isolation and characterization

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 

Extractable and leachable studies

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

Custom Peptide Synthesis and Analytical Development 

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

Success stories in contract research

of a parenteral grade API involving carryover of a toxic cyanide compound


Successfully developing a customized and cost-effective ICH Q3D analytical method along with risk assessment for an inhalation grade drug undergoing clinical trials in the EU