Pre-IND Drug Discovery and Safety

Unparalleled expertise, with proven results

Accelerate Your Success

Partnering with us means more than just accessing best-in-class preclinical GLP testing. It means having a dedicated and experienced team by your side, committed to guiding you through regulatory submissions and ensuring that your pre-IND and CTA applications are positioned for success.

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What You Get

Experience That Counts: Benefit from our team's extensive experience in preclinical GLP testing and regulatory submissions. Our track record of successful IND and CTA applications speaks to our commitment to excellence and our deep understanding of regulatory requirements.

Tailored Solutions, Competitive Pricing: Experience the advantage of customised testing solutions that are aligned with your specific needs and budgetary considerations. Our competitive pricing ensures that you receive exceptional value without compromising on the quality and reliability of our services.

Accelerated Turnaround Time: Stay ahead of your timelines with our streamlined processes and commitment to fast turnaround times. We recognise the importance of time in the drug development process and are dedicated to delivering timely and accurate results.

Comprehensive GLP Testing Assays: Access a comprehensive range of GLP-compliant preclinical testing services, including pharmacology, toxicology, ADME, and safety pharmacology assessments. Our state-of-the-art facilities and cutting-edge technology enable us to deliver precise and insightful data for informed decision making.

Our tailored preclinical safety and efficacy testing solutions advance your regulatory applications along the path to success.

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Medicilon and Hoeford Research offer Drug Discovery and Safety from their collaborative global labs

As biotechnology, biopharmaceutical and pharmaceutical companies approach the Investigational New Drug (IND) or Clinical Trial Application (CTA) phase, the emphasis on robust and comprehensive drug discovery and safety/efficacy testing becomes paramount, and choosing the right testing partner emerges as a cornerstone in this process.

The synergy between the drug developer and the testing partner enables seamless integration of different testing types within a consolidated platform. This impacts the drug's development journey by streamlining and optimising the regulatory testing process, ensuring compliance while significantly influencing cost management and shortening the time to market - a critical competitive advantage.

Drug discovery and safety timeline for pre IND application

Hoeford and Medicilon are dedicated to providing drug developers with a comprehensive portfolio of preclinical drug discovery and safety testing services to support pre-IND and CTA applications. With our commitment to competitive pricing, fast turnaround, and extensive expertise in successful IND and CTA submissions, we are your ultimate ally in achieving regulatory milestones with confidence.

The safety and efficacy testing platform encompasses the full spectrum of integrated GLP-compliant testing to address every aspect of regulatory and market success.  These include:

Acute Toxicity Testing
  • Determines the substance's potential to cause immediate harm after a single exposure, providing crucial information for hazard classification and initial risk assessment.
  • Required by regulatory agencies to establish safe starting doses for further toxicity studies and to identify substances requiring immediate risk management.
Genotoxicity Testing
  • Identifies substances capable of damaging DNA, which can lead to mutations and cancer. Crucial for assessing long-term safety and carcinogenic potential.
  • Regulatory requirement to ensure the safety of pharmaceuticals, food additives, and industrial chemicals, belong prevent potential harm to human health and the environment.
Repeat Dose Toxicity Studies
  • Evaluates the effects of prolonged exposure to a substance, mimicking real-world scenarios and assessing cumulative toxicity. Vital for understanding chronic health risks.
  • Provides critical data for setting exposure limits, informing risk assessments, and guiding regulatory decisions regarding safe usage levels in various applications.
Pharmacokinetic Studies
  • Examines how the body absorbs, distributes, metabolises and eliminates a substance (ADME). Crucial for predicting its behaviour in humans and optimising dosage regimens.
  • Essential for understanding bioavailability, potential drug interactions, and metabolic pathways, guiding the development of safe and effective pharmaceuticals.
Carcinogenicity Testing
  • Identifies substances capable of causing cancer, providing essential data for risk management and regulatory decision-making.
  • Regulatory requirement for pharmaceuticals, pesticides, and industrial chemicals to protect public health and minimise exposure to carcinogens.
Reproductive Toxicity Studies
  • Evaluates the potential of a substance to harm reproductive organs, impair fertility, or cause developmental defects. Critical for protecting maternal and foetal health.
  • Essential for assessing risks to human reproduction and guiding regulatory decision regarding the use of chemicals in consumer products and environmental management.
Immunotoxicity Studies
  • Assess the impact of a substance on the immune system, crucial for identifying immunosuppressive agents or allergens and understanding their potential health effects.
  • Helps ensure the safety of pharmaceuticals, vaccines and environmental chemicals. Particularly important for vulnerable populations with compromised immune systems.
Neurotoxicity Screening
  • Identifies substances capable of damaging the nervous system, including the brain and peripheral nerves, crucial for protecting cognitive function and neurological health.
  • Essential for assessing the safety of drugs, pesticides and industrial chemicals to prevent neurodevelopmental disorders, cognitive impairment, and neurodegenerative diseases.
Skin Sensitisation Testing
  • Determines if a substance can trigger allergic reactions upon skin contact, crucial for preventing skin sensitisation and allergic dermatitis in humans.
  • Regulatory requirement to ensure the safety of medicines, cosmetics, personal care products, and chemicals used in consumer goods, minimising the risk of skin sensitisation and related health issues.
Phototoxicity Testing
  • Identifies substances that can cause skin irritation or damage upon exposure to light. Critical for assessing the safety of topical medications, cosmetics, and chemicals used in sunscreens.
  • Helps protect human health by preventing phytotoxic reactions, including sunburn, photosensitivity and photo dermatitis caused by exposure to photosensitising agents.
Haemocompatibility Testing
  • Evaluates the compatibility of a substance with blood components, essential for ensuring the safety and efficacy of medical devices, implants, and blood-contacting materials.
  • Regulatory requirement to minimise the risk of adverse reactions such as clotting, haomolysis and thrombosis, which can lead to serious complications in patients.
Systemic Toxicity Testing
  • Assess the effects of a substance on various organ systems, providing critical data for understanding systemic toxicity and guiding risk assessments.
  • essential for evaluating the safety of pharmaceuticals, chemicals and consumer products to protect human health and minimise the risk of adverse effects on organ function.
Inhalation Toxicity Studies
  • Evaluates the adverse effects of inhaling a substance, crucial for assessing respiratory toxicity and guiding risk management strategies for occupational and environmental exposures.
  • Regulatory requirement for assessing the safety of inhaled pharmceuticals, occupational chemicals and environmental pollutants to prevent respiratory disorders and lung damage.
Biocompatibility Testing
  • Assesses the compatibility of a substance with biological systems. Crucial for ensuring the safety and performance of medical devices, implants and biomaterials.
  • Essential for preventing adverse reactions such as inflammation, infection, and tissue rejection, ensuring the biocompatibility and long-term viability of biomedical products and therapies.
Regulatory Consultation and Strategy
  • Advisory services for understanding regulatory requirements and pathways.
  • Assistance with the preparation on nonclinical sections for regulatory submissions.
Risk Management Reporting

Comprehensive risk assessment reports highlighting potential areas of concern and proposed mitigation strategies.

Detailed plans for managing and mining risk during the pre-IND phase.