NCBiologics offers its expertise in innovative & biosimilar projects consulting on, and managing the following:

Assay development & validation

• Potency
• Ligand binding assays
• PK
• Test method qualification / validation / tech transfer
• Cell banking advice / evaluation
• Identification /oversight of CROs

Drug Substance / Drug Product testing

• Batch release testing
• Setting release specifications
• Reference Standard characterization
• Stability testing
• Process / product comparability

Pre-clinical testing

• Pharmacokinetics
• Pharmacodynamics

Clinical testing

• Pharmacokinetics
• Pharmacodynamics
• Neutralizing antibodies

Regulatory documents and communication with agencies (FDA & EMA)

• Advice on regulatory / development strategy for bioassays and bioanalytics
• CMC section of regulatory submission - preparation/ review
• Product characterization package for scientific advice meeting
• Pre-clinical bioanalytical testing - assay development / submission preparation / review
• Clinical bioanalytical testing - assay development / preparation / review
• Communication and meetings with regulatory agencies


• Due diligence audits and assessments
• CRO compatibility to specific bioassay / ligand binding assay performance
• GMP compliance to release testing
• GLP compliance to clinical sample testing

Scientific and Regulatory Due Diligence

• Evaluation of biotechnology projects, covering all phases of product development including: CMC, pre-clinical, clinical and regulatory interactions
• Evaluation of biotechnology companies, covering review of business plans, scientific, regulatory, and CMC evaluation
• Assessment of patentability
• Identification of project’s /company’s assets as well as weaknesses and limitations

.....according to EMA, FDA and ICH regulations