IND Enabling Services
IND Enabling Study Services in India
Conducting IND-Enabling Services involves several steps, and with proper preparation, they can be carried out efficiently. Our team of scientific and regulatory experts is available to guide you through the process, assisting in addressing crucial questions to meet regulatory standards. This support ensures that you can adhere to your development timelines and achieve milestones within your IND program effectively.
How to Prepare for a Successful IND Program:
Awareness of Time Requirements: Recognize that preparing for an Investigational New Drug (IND) program can take up to 18 months.
Analytical Methods Development: Allocate time to identify and develop suitable analytical methods crucial for preclinical testing.
Batch Production and Characterization: Understand the need to produce and characterize investigational new drug batches that are both appropriate and sufficient for preclinical evaluation.
Thorough Understanding of Therapeutic Target: Success hinges on a deep understanding of the human therapeutic target, treatment schedule, disease indication, and clinical trial design. This knowledge is crucial for identifying safety assessment studies required for first-in-human trials.
Critical Questions Before Seeking a Quote: Address essential questions before requesting a quote for your investigational new drug program.
Aligned Preclinical and Clinical Strategies: Ensure alignment between preclinical and clinical strategies to facilitate adjustments and changes as needed.
Time Allocation for Preparation: Allocate sufficient time for preparation and preliminary testing before launching the pivotal IND program.
Manufacturing and Characterization Planning: Plan appropriately for the manufacturing and characterization of your test article, a critical aspect of conducting successful IND-enabling studies.
CUSTOM IND Services in INDIA:
Vipragen collaborates with clients to design and execute Investigational New Drug (IND) programs, ensuring success within specified timelines and budgets. Our customized approach considers the drug type, administration route, and clinical indication, led by a team of scientists and program management professionals. With expertise in Cell and Gene Therapy (CGT), we offer precision-focused support for first-in-human (IND-enabling) programs, guiding clients through the unique challenges of these innovative therapies. Our multidisciplinary team provides comprehensive support, ensuring a successful journey from program initiation to completion.
IND Program Support
- » Accelerated IND-enabling Studies and Timelines
- » Transporter Assays
- » Candidate Selection
- » Drug Metabolism and Pharmacokinetics
- » Analytical and Bioanalytical Assay Development and Validation
- » Safety Assessment
- » Formulation Analysis
- » Bioanalysis
- » ADME
- » Immunogenicity Testing
- » Screening and Preliminary Toxicology
- » Repeat-dose Toxicology
- » Safety Pharmacology
- » Genetic Toxicology
Therapeutic Area Expertise
- » Cardiovascular
- » Inflammation
- » Ophthalmology
- » Musculoskeletal Disease
- » Respiratory Disease
- » Immunology
- » Metabolic Disease
- » Neuroscience
- » Infectious Disease
- » Microbiome Research
- » Renal Disorders
- » Oncology
Support Services
- » IND Program Regulatory Support
- » SEND
- » Scientific Advisory Services
IND Program Expertise:
Vipragen brings a demonstrated track record in conducting IND-enabling studies and facilitating the market entry of our clients' investigational new drugs. Through an unparalleled array of services and top-tier expertise, we assist clients in effectively commencing and concluding their IND-enabling programs within specified timelines and budgets. As a global Contract Research Organization (CRO), we harness this extensive experience to craft tailored studies or programs suitable for submission to regulatory authorities worldwide.