GLP Complaint

For Pharmaceuticals (US FDA /EMA /CDSCO) and Agrochemicals (US EPA / CIB&RC /ECHA)

Acute studies (Acute Oral Toxicity Study OECD #420, #425 and #423; Acute Dermal Toxicity Study OECD #402)
Pyrogen Test (Indian Pharmacopeia)
Skin Irritation /Corrosion Test in Rabbits OECD #404
Eye Irritation /Corrosion Test in Rabbits OECD #405
Guinea Pigs Sensitization Study (M&K and Buehler's Method) OECD #406

For Medical Devices (US FDA /EMA /CDSCO)

Area(s) of Expertise

Toxicity Studies

Acute Toxicity

Eye Irritation/ Serious Eye Damage (in vivo)

Pyrogenicity

Skin Irritation/ Corrosion (in vivo)

Skin Sensitization (in vivo)

Mutagenicity Studies

Bacterial Reverse Mutation (AMES) Test

Others

Biocompatibility Studies

Method Validation

Agrochemicals,

Medical Devices (Applicable only for Bio-compatibility, not applicable for Batch Release parameters required as per MDR, 2017)

Pharmaceuticals (Human)

Agrochemicals,

Medical Devices (Applicable only for Bio-compatibility, not applicable for Batch Release parameters required as per MDR, 2017)

Pharmaceuticals (Human)