Frequently Asked Questions

FAQs

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FAQTrans-Genica

How to enquire for Trans-Genica services?

We are happy to provide a quote based on your testing requirements.

Please provide the details of testing requirements to info@trangenicresearch.com and we will be happy to talk to you on phone or virtual call before sending the quotation.

How do I pay for Trans-Genica services offered?

We will raise the invoice once the scope of work is finalized. Payment information is provided on the invoice. You can pay via credit card, or bank transfer, please contact info@trangenicresearch.com  for more information and kindly mention the quotation number.

Is your testing facility certified?

Yes. Trans-Genica animal facility is the state-of-the-art, environment-controlled facility approved by CCSEA (Committee for Control and Supervision of Experiments on Animals), Department of Animal Husbandry and Dairying (DAHD), Ministry of Fisheries, Animal Husbandry and Dairying (MoFAH&D), with the registration number 2105/PO/RcBt/S/20/CPCSEA.

All animal experiments (procurement and use of animals) are conducted only after due and proper approval of each and every project (experiment / study) by the IAEC (Institutional Animal Ethics Committee).

What animal models are available for preclinical studies?

At Trans-Genica, we conduct studies using following rodents and nonrodents models

Small Animal Models 

Rodents (mice, rats, hamsters) and

Nonrodents (guinea pigs, rabbits).

Based on the client requirements, we also work with the Immunodeficientimmunocompromised and transgenic or other genetically modified animal models. We provide custom tailored services based on the client needs.

FAQTrans-Genica

What are the main study types and services offered by Trans-Genica?

At Trans-Genica, we offer following study types:

  • Invitro Genotoxicity studies
  • Efficacy testing
  • Single Dose and Multiples Dose studies
  • Repeated Dose studies
  • Acute, Sub Acute and Chronic Toxicity studies
  • Neurotoxicity studies
  • Genotoxicity studies
  • Alternative toxicology studies
  • Safety Pharmacology
  • Biological evaluation of Medical Devices
  • Acute 5 pack studies for Agrochemical product testing
What routes of administration does Trans-Genica use?

Based on the study objective, duration, and the species used, the routes of administration for in-vivo studies are mainly;

oral
intravenous
dermal

Along with the above regular routes, below mentioned routes are also used as per project and study needs:

subcutaneous,
intradermal,
intraperitoneal,
ocular,
intraarticular,
intrathecal or
intracranial

We have the expertise (trained and experienced manpower /staff) and know-how available for the above routes of administrations

Kindly inquire if you do not see a dose route you are looking for. Trans-Genica has developed a network of veterinary specialists and scientists that can assist us in bringing new dose routes on board for study needs.

What is the lead time for preclinical testing?

Preclinical testing time duration varies based on study type and species. At Trans-Genica, we can start a regular preclinical study within 2-4 weeks of a signed agreement. In case there are special requirements like procurement of transgenic animals or a specialized instrument, total lead time may be 2-3 months from the signed agreement.

What happens after signed contract agreement for a preclinical study with Trans-Genica?

Once a contract agreement is signed, Project manager and study director from Trans-Genica will keep the client updated with project status throughout the study duration. Our team works together with our valuable clients to ensure seamless communication throughout the study proposal, initiation, project setup, and execution.

At Trans-Genica, we have client centric policy. Our study directors manage a limited number of studies at one time to ensure that our clients get the data, clarifications for queries, or any unexpected study modification suggestions on time.

FAQTrans-Genica

What is the turn-around-time (TAT) for any project?

The TAT of any project will depend on the experimental period which in most of the cases dependent on the specified national and international guidelines. Over and above the experimental period, we take minimum time for the start of the study and preparing report after the experimental completion, thus keeping the TAT to least possible. This will be discussed and agreed upon before finalization of the contract.

What type of drug modalities or product samples are tested at Trans-Genica CRO facility?

At Trans-Genica, we can conduct in-vitro and in-vivo studies for many therapeutic indications. We conduct efficacy, toxicology, safety, testing for any drug modality for small and large molecule drugs, medical device product testing, biotech and agrochemical products, industrial chemicals, food and beverages testing samples.

What regulatory guidelines are followed at the Trans-Genica CRO facility?

At Trans-Genica, most of our studies are as per the OECD Guidelines.

We also use other guidelines like ICH, ISO 17025, OPPTS (now OCSPP), CDSCO, CIB&RC, Indian/US/British Pharmacopoeia, etc.

The selection of the guideline depends on the clients /sponsor (Pharmaceutical / Agrochemical / Biotech / Medical Device or other Companies, etc.), the test material / substance / item (Pharmaceutical / Agrochemical / Biotech product / Medical Device / /Industrial chemicals, etc.), region where data is to be submitted (India / APAC / EU / NA /Latin America / ROW, etc).

What regulatory processes are followed at the Trans-Genica CRO facility?

At Trans-Genica, all our in-vivo studies are conducted in accordance with CCSEA (Committee for Control and Supervision of Experiments on Animals) an Indian Governmental body managing ethical animal’s research. We are committed to make sure all our animal colonies are looked after properly as per the standard ethical guidelines by strictly following the 4R Principles on Experimental Animals.  All our experiments are governed through Institutional Animal Ethic Committee (IAEC). At Trans-Genica, all our scientists working with animal models and industry experienced veterinarian ensures compliance of Institutional Animal Welfare policies.

FAQTrans-Genica

What supporting services do you offer at Trans-Genica?

We offer scientific, regulatory and strategic guidance through our industry experienced expert consultants, we offer services with protocol development, project management, analytical chemistry, bioanalysis for small and large molecules, toxicokinetic, pathological examination, project report preparation. If you have specific query, do write to us at info@trangenicresearch.com.

If as a sponsor or client we want to visit Trans-Genica, can we do so and how to reach there?

We at Trans-Genica, always recommend our sponsors and clients to visit us and see for themselves our facilities and infrastructure. We are always welcoming any visitors (clients /sponsor/ inspectors /auditors, etc.) to our facility and look forward to valuable constructive feedback.

Please get in touch with us for your visit and we will guide you on how to reach the Pachora /Jalgaon (the nearest railway station) or bus station. We will arrange for the pick up from the nearest station and will also drop you to the nearest station.

In case an overnight stay is required, we can help you in arranging the stay in nearby good hotels.

What is your Organizational stand on PG /Ph.D. Students / Programs?

We offer our facilities, infrastructure and resources to the students for their PG/PhD works, in case their institutes /organizations do not have any of the facility or resource required for their research work. This is not for profit work for us and we extend our support to the students at a very reasonable cost (only to recover our expenses), so that students can complete their research projects. Please connect for your specific requirements.

We also recommend and encourage our staff to go for higher studies like PG /PhD programs while on our payroll and we offer all our support, facilities and infrastructure to complete their research work at Trans-Genica.

Are you open to collaborate with Academic Institutions or Research Projects or other organizations?

Yes. We are open for all types of Research Collaborations with different organizations.

Please connect with us for any collaborative research or regulatory works. We encourage collaboration of any and all sorts possible for better and optimal utilization of scientific expertise, manpower, facilities and infrastructure of all collaborating organizations /labs.