Biological Sample- ICMR

Biological Sample- ICMR

Introduction

Perhaps the most important leg of clinical research are biological products and their procurement. Often research and product launches are delayed due to red tape and paperwork over government guidelines at this very initial step. CliniExperts specializes in cutting through this chaos and setting your clinical research on a smooth sailing journey right from this step. We understand the importance of timelines and function as a well-oiled machinery that can deliver services on the expected date and time, glitch- free.

By applying technology, creativity and focused multi-disciplinary approach, internally as well as externally, we improvise processes and accelerate approvals. Our service aims at leveraging models that are cost effective in the long run and help in growth of new products along with sustenance of established products. We commit to periodic and smooth safety reporting to regulatory authorities and global Ethics Committees.

The Indian Council of Medical Research (ICMR) has set stringent guidelines and certificates to be obtained for various types of biological material samples. It regulates by way of periodical revisions in addition to approvals from CDSCO. Approvals are also required by other offices and agencies at the district, zonal state and national level.

1. NOC for Import and Export – We assist in obtaining Import & Export licenses for biological and their registration. Our dedicated team of regulatory experts expedites the process of import for IMPS, equipment’s, and ancillary supplies. We help in obtaining Import Permits and compiling necessary documents for the same.
2. NOC for vaccines/ rDNA products – In 1990, the Govt. of India set guidelines for Recombinant DNA usage safety guidelines. In the process of framing the guidelines, the committee considered local factors, resistance to infection, laboratory environment, host parasite statistics in the country, survival chances etc. that are specific to our tropical climate. DNA and genomics form a substantial part of clinical research today. Registrations and licenses are required by the following authorities for procurement and use of the same by the following authorities-
   • Genetic Engineering Approval Council (GEAC);
   • Recombinant DNA Advisory Committee (RDAC);
   • Review Committee on Genetic Manipulation (RCGM);
   • Institutional Biosafety Committees (IBSC);
   • State Biosafety Coordination Committees (SBCC);
   • District Level Committees (DLC).

   New licences must be obtained by the importing party for products utilizing rDNA technology, even though the product is physically/chemically similar to existing naturally occurring products or existing products in the conventional system. The products must clear all safety guidelines for the packaging of the samples, and manner of import. CliniExperts can help you ensure thorough compliance at every step of your import.

3. NOC for Saliva – As more and more studies are using saliva as an important sample for biomarkers and creation of easy testing methods, it is imperative to obtain high quality saliva samples easily. Our team streamlines the procurement of NOC for saliva samples for clinical studies and research. The TMC- Institutional Ethics Committee- III established in 2009 has mandated guidelines for ethical and scientific reviews of studies using saliva as part of their study. NOC must be obtained from the committee to use saliva.
4. NOC for Blood – Blood is a constant and indispensable part of clinical research. Our experts are adept at navigating through the guidelines and obtaining NOC for blood samples needed for just about every clinical study. The cumbersome paperwork and endless guidelines often lead to delays in approvals, processing and final onset of the study. CliniExperts ensures that all the necessary documents and details needed by the guiding authorities are in place to expedite the process.

Challenges associated with approvals/NOCs:

To initiate a study requiring biological samples is not easy. Many obstacles plague the approval process from authorities. Yet, it is not impossible if you are well prepared with all the necessary documents and answers that the regulatory authorities demand to clear your NOC applications. With CliniExperts on your side, you will never have to worry about a missed deadline. Our senior regulatory experts are dedicated to maneuvering swiftly through ethics approvals and complex regulatory processes so that studies and product launches start off on the right foot, timely.

1. Clinical Trial approval – production, compilation and submission of application for clinical trials. The application for initiating a clinical trial in India requires extensive paperwork from multiple authorities at local and national level. It needs comprehensive information about the trial like details of the dosage being used (form, composition, etc.), complete pharmaceutical information about the drug to be used, all animal pharmacologic and toxicological data, etc. A clear cut approach to the trial, its various phases and patient details must be provided to get the approval. Documents must be submitted for everything.CliniExperts team of professionals ensures comprehensive compilation of all necessary documents ensuring submission goes through in the first go and no delays occur. We aid our clients in obtaining trial approvals hastily.
2. Product registration – At CliniExperts we understand the importance of timely product registration. Our experienced team of regulatory experts assists our clients in accomplishing end to end product registration process. Our team helps in the following services-
   • Preparation and/or review of applications/dossiers
   • Bridging the gap between available literature and queries of new conditions. This is especially necessary when there are changes in product manufacturing processes or their dosage, storage, packaging that can change its efficacy/stability of the pharmaceutical product
   • Summaries and reports content ideation and creation

   Our strong networks with health authorities and regulatory committees gives CliniExperts a bird’s eye view of the entire process without missing out strategic details.

Services provided by CliniExperts:

CliniExperts provides end to end registration and licensing assistance for biological samples as well as vaccines and sera.

• We help in obtaining the test licenses and getting product approvals for vaccines and biological samples.
• We cater to client needs of market authorization and constantly strive to simplify the process at every level.
• Our commitment to provide complete client satisfaction means we assist with any post-approval changes at any step of product launch, etc.