Pre-Clinical Services

Pre Clinical Research and Development

At RCS, our Pre-Clinical Services encompass both in vitro and in vivo studies, tailored to advance the development of cell-based therapies, proteins, vaccines, chemicals, and medical devices. We provide comprehensive expertise in non-GLP and GLP safety assessments across a diverse range of species, including both rodent and non-rodent models. Our services are designed to thoroughly evaluate Nutraceuticals, Biopharmaceuticals, pharmaceuticals, biologics, animal health products.

Our scientific and regulatory teams collaborate to develop customised research programs, conducting preclinical studies that are meticulously designed to meet your specific needs. Whether you're working towards an IND or NDA submission, our goal is to ensure that your toxicology, safety pharmacology, and laboratory studies are in full compliance with global regulatory standards.

• 16 Years of Preclinical Excellence

• GLP-Certified & AAALAC Accredited facility

• Diverse In Vivo & In Vitro Expertise

• Broad Species Coverage

• Global Regulatory Expertise

• Extensive expertise in medicinal chemistry, custom synthesis, process R&D, and scale-up

• Cutting-Edge Analytical Technologies (BIACORE-based assays, HPLC, and LC-MS for detailed product characterisation and biomarker analysis.

• Fully automated clinical and histopathology laboratory with highly skilled pathologists and technicians

• Animal Facility registered with the Committee for Control and Supervision of Experiments on Animals (CCSEA) and conforms to its guidelines.

Our services

Equipped to support pivotal toxicology, safety pharmacology, and laboratory solutions for small and large molecules, ensuring your submissions meet global regulatory requirements.

Pre-Clinical Screening and Lead Optimization

• In Vitro Screening and Mechanistic Studies

• In Vivo Efficacy and Disease Models

• (PK/PD) Studies

• Toxicology and Safety Pharmacology

• Drug Metabolism, Formulation Development, and Lead Compound Selection

Pharmacology Studies

• Receptor Binding Studies

• Cell-Based Function Assays

• Enzyme Inhibition Assays

• Pharmacokinetic Studies

• Pharmacodynamic Studies:

• Dose-Response Studies

Pharmacokinetics/ Pharmacodynamics Studies

• Dose-Response Relationship and Target Engagement

• Single and Multiple-Dose Pharmacokinetics

• Bioavailability and Bioequivalence Studies

Invivo Studies

• Pharmacokinetic Studies

• Pharmacology Efficacy Studies

• Safety Assessment Studies

• Dose Range Finding Studies

• Pharmacodynamics Studies

Invitro Studies

• Cell-based Assays

• Biochemical Assays

• In Vitro Pharmacology

• Toxicology Screening

• ADME Studies

Toxicology Studies

• Acute Toxicity Studies

• Chronic Toxicology Studies

• Subchronic Toxicology Studies

• Carcinogenicity Studies

• Immunotoxicology Studies

• Local Tolerance Studies

Safety Pharmacology Studies

• Cardiovascular Safety Testing

• Central Nervous System (CNS) Safety Evaluation

• Respiratory Function Assessment

• Gastrointestinal Safety Studies

Immunology/ Immunotoxicology Studies

• Immune Response Assessment

• Hypersensitivity and Anaphylaxis Testing

• Immunosuppression and Immunostimulation Studies

• Chronic Immunotoxicity Evaluation

Bioanalytical Services

• Method Development and Optimization

• Sample Analysis

• Biomarker Analysis

• Data Processing and Reporting

• Regulatory Support

Animal Models and Administration Routes

Our expertise spans a wide range of animal models and administration routes, including rodents, nonhuman primates, and various delivery methods such as oral and dermal. We ensure thorough and precise studies tailored to meet every specific requirement.

• Rats

• Mice

• Guinea Pigs

• Rabbits

• Swine

• Miniature Swine

• Dogs

• Non-Human Primates (Cynomolgus, Rhesus, etc.)

Species Expertise

• oral

• parental

• infusion

• ocular

• dermal

• implant

• intravaginal and intrapenile

• rectal

Route of Administration

Animal Walfare in Pre-Clinical Research

At RCS, we prioritize animal welfare in all our preclinical research. Our CCSEA-approved facility ensures that our procedures align with the highest ethical standards. Our staff is extensively trained in laboratory animal care, emphasizing humane treatment and environmental enrichment. We adhere strictly to regulatory guidelines, ensuring compassion and sensitivity in every aspect of our research practices.

• CCSEA Approved Animal Research Facility

• Registered IAEC

• GLP Certified and NABL Accredited lab facilities

• ISO 9001:2015, ISO 45001:2018, ISO 27001:2013 certified 

Experienced Study Directors

With Extensive industry experience, our study directors ensure that each study is conducted with the highest standards of quality, integrity, and scientific validity. They work closely with clients to develop customized study protocols tailored to meet specific objectives and regulatory requirements, providing expert guidance and support throughout the study lifecycle.

Skilled Investigators

Our team of skilled investigators is comprised of scientists with diverse backgrounds and expertise in various preclinical disciplines. They are committed to conducting studies ethically and in accordance with international guidelines, ensuring the welfare and humane treatment of research animals at all times