Guidances & Regulations
Guidances FDA
- Guidance for Industry Bioanalytical Method Validation
- Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
- FDA Draft Guidance Biosimilars
- Guidance for Industry Assay Development for Immunogenicity Testing of Therapeutic Proteins
Guidances EMA
- Biosimilars containing Erythropoietin
- EMA Guidelines on Validation of Bioanalytical Methods
- EMA guidance immunogenicity
- • Guidance for Laboratories that perform the Analysis or Evaluation of Clinical Trial Samples
- Guideline On The Investigation of Bioequivalence
- Guideline similar biologics quality issues
- Immunogenicity assessment of monoclonal Antibodies
- Similar biological medicinal products non-clinical and clinical issues
GLP Regulations
