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Do you need an experienced R&D Director or Project Management team to handle your preclinical drug development?
We could be your R&D partner, as part of your senior management team, and help implement your preclinical drug development from lead molecule to IND filing in a time-efficient manner. ClinTech Research is continually establishing business relationship with vendors offering preclinical pharmacology & toxicology as well as drug substance/ drug product clinical trial material manufacturing; and has an extensive network of strategic partners, and collaborator consultants with 100+ yrs experience in drug development including regulatory submissions. We can quickly start projects, saving significant time and resources to our clients. In addition, our designated technical project manager will work closely with your study team to manage your entire project and to ensure two-way communication through a single-point-of-contact in the USA.
ClinTech Research is an independent service company, and do not broker/represent vendors, or receive fees, or kickbacks from vendors. Our selection of CROs and CMOs for our clients is driven by a business philosophy to identify the right partner to fit the client's needs for the particular task at hand. We are dedicated to ensure the smooth progress of nonclinical programs in accordance with your needs and regulatory requirements, and we will partner with you to create solutions that are specially tailored to meet your needs.
Our preclinical CRO network includes internationally recognized research institutions, AAALAC, USDA, GLP-compliant vendors primarily in the USA and in India offering both GLP-compliance regulatory toxicology studies for Investigational New Drug (IND) application as well as non-GLP pharmacology and toxicology studies in order to provide preliminary assessment of a drug's safety and efficacy. On the other hand, our CMOs are GMP-compliant vendors offering CMC development including manufacturing process development, pre-formulation/ formulation development, analytical method development & validation, clinical trial material manufacturing, packaging and stability studies required for the submission of an IND.
Our preclinical development services include:
For manufacturing, we have network of vendors who could handle from early chemistry custom synthesis of analog library, formulation process development to GMP clinical trial material manufacturing for proof-of-concept clinical trials, and are as follows;
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For pharmacology and toxicology, we have network of vendors who could handle from early efficacy animal models to IND-enabled Safety Pharmacology and Toxicology studies, and are as follows;
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ClinTech Research provides a broad range of regulatory expertise and services to ensure that your program runs seamlessly into clinical development. Our team of consultants has more than 100 years of experience in drug development/regulatory including: pre-IND and IND preparation and submissions; pre and post-IND and NDA meetings with the FDA; and the preparation and submission of NDAs, ANDAs and 505(b)(2) NDAs., IDE etc.
Our regulatory support services include:
- Initial Pre-IND & IND package preparation, management, and submission.
- Act as the primary contact to the FDA on behalf of a US sponsor, or as an US Agent on behalf of a non-US sponsor.
- Technical writing of the Chemistry Manufacturing and Controls (CMC), Nonclinical (pharmacokinetic, pharmacology, and toxicology sections), and Clinical (Investigator’s Brochure, Protocol, ICF etc) sections of the IND application.
- Pre and post-IND and NDA meetings with the FDA; and the preparation and submission of subsequent 505(b)(2) NDAs, 510k, IDE etc
If you have any questions or would like a more detailed description of our preclinical development services, please Contact Us.
