OUR SERVICES
Somatek’s service offerings focus on Chemical Methods and Controls (CMC) for FDA and EMA regulated biologics.
Outsource Management
- RFP generation and bidding process
- CMO/CRO selection and negotiations
- project/program management
- routine and for cause audits
Process Development & Manufacturing
- antibodies, ADCs, other constructs
- enzymes, cytokines, fusion proteins
- viruses (adenovirus, AAV, lentivirus, etc.)
- diagnostics (IVD, POC, imaging agents)
Assay Development / Establishment
- biochemical and cell based assays
- in vivo model development
- toxicology & pharmacology
- assay characterization
Quality Assurance (QA)
- document systems and controls
- facility & equipment IQ/OQ/PQ
- processes qualification & validation
- quality systems and training
Formulation/Stability
- liquid and frozen formulations
- lyophilization formulations and methods
- product stability and characterization
- accelerated/forced degradation
Quality Control (QC)
- assay qualifications
- assay validations
- materials testing
- microbiology
Audits, Due Diligence, Investigations
- chemical methods & controls (CMC)
- project feasibility (resources, timelines)
- compliance (FDA, EMA, GMP, ISO, ICH)
- failure analysis (OOS, root cause, gap)
Regulatory Affairs and Strategies
- chemical methods & controls (CMC)
- pre-IND preparations
- agency interactions (FDA, EMA)
- filings (INDs, annual reports, BLAs)
Research Products
- development
- research reagents
- kits