NYK BioSolutions

These studies are critical for regulatory toxicology, helping to identify risks of chemicals to human reproduction and development. They also guide regulatory decisions for safe human and environmental exposure limits.

Acute toxicity studies are a cornerstone of toxicological research and chemical safety evaluation. They are crucial for determining the initial safety profile of substances, guiding regulatory decisions, and ensuring public and environmental health Acute Toxicity study determines the toxic potential of a substance after a single exposure. and help to identifies the dose range that causes harm or fatality, aiding in risk assessment. ITs a essential requirements for Regulatory Compliance for drugs, medical devices, chemicals etc and help the authoritied to categories product as per GHS Classification.

Determines the specific organs or systems affected by repeated exposure to the test substance that helps to identify early signs of toxicity that may not manifest after a single exposure. along with this the relationship between dose levels and toxic effects, which is essential for risk assessment. Supports the establishment of safe exposure limits for humans and the environment. Essentials regulatory requirements as per OECD and ISO Guidelines. Sub-acute toxicity studies are essential for understanding the safety profile of substances following repeated exposure. They provide a foundation for regulatory safety evaluations, support the development of safe products, and ensure compliance with international guidelines, ultimately safeguarding human health and the environment.

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Genotoxicity studies evaluate a substance's potential to damage the genetic material (DNA) in cells, which can lead to mutations, chromosomal abnormalities, or cancer. These studies are essential for assessing chemical, pharmaceutical, and environmental safety. Regulatory agencies worldwide require genotoxicity data to ensure the safety of drugs, chemicals, cosmetics, and other products.

Skin irritation studies as per OECD guidelines play a crucial role in ensuring the safety of Industrial chemicals,Pesticides. Drugs, cosmetics and products for human use. The guidelines provide scientifically validated methods, emphasizing alternatives to animal testing wherever possible, thus balancing regulatory needs, human safety, and ethical considerations.

Is the process of testing chemical compounds or biologics to identify potential candidates for treating specific diseases. It is a critical step in the drug discovery pipeline, aiming to identify compounds with therapeutic potential before advancing them into preclinical and clinical development. Following are the steps in Drug Compound Screening:

Compound Library Preparation: Large libraries of diverse chemical entities, including natural products, synthetic compounds, or biologics, are curated.
Assay Development: Design of sensitive and reliable assays (in vitro or in vivo) to measure activity against the target or phenotype.
Primary Screening: Initial testing of the library to identify "hits" – compounds showing desired activity.
Secondary Screening: Validation of hits to confirm activity and eliminate false positives. Includes counter-screening for off-target effects.
Preclinical Validation: Testing optimized compounds in disease models for efficacy, safety, and pharmacokinetics.

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Chronic toxicity studies are conducted to evaluate the long-term effects of repeated exposure to a substance ( Drug, Chemicals , Pesticides, Cosmetics etc) over a significant portion of an organism's lifespan. These studies are essential for assessing risks associated with prolonged human exposure to chemicals, pharmaceuticals, and other products. The OECD guidelines provide a standardized framework for conducting chronic toxicity studies to ensure reliability and regulatory compliance. These studies are indispensable for understanding the long-term safety of substances and are critical for regulatory approval. The data generated provides a foundation for setting exposure limits and ensuring public health and environmental safety. The OECD guidelines ensure that these studies are conducted consistently, ethically, and scientifically.

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Cosmetics testing (in vitro) and proof of concept studies to support patent grant

R&D based customised services based on proposal. Reach out to us for more details.

Cell line characterisation and genetic stability studies in MCB, WCB and EoP cells as per ICHQ 5 guidelines.

In-vitro immunogenicity using PBMCs

Toxicity and efficacy studies on in vitro disease models of cancer, Diabetes, Inflammation, Pulmonary disease, Psoriasis and Osteoporosis.

Flow Cytometry Assays

Gene expression Assays

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Syngeneic and xenograft models

Asthma Model

Lung Inflammation and Fibrosis Model

Chronic Obstructive Pulmonary Disease (COPD) Model

Absolute Bioavailability Studies

PK/PD Studies (Pharmacokinetics/Pharmacodynamics)