Biological Regulatory services
Biologicals are the medicinal, therapeutic/ diagnostic/ preventive preparations that are prepared from living organisms and their products for human use. They include serums, vaccines, antigens, antitoxins, etc. Biotechnology is used as a unique approach in manufacturing such medicinal agents. We provide all round support in the manufacturing and import of biological products, vaccines, etc. in India, assisting our clients in detailed filing of dossier as required and do rigorous and careful verification so as to successfully file the application in one go.
4For Manufacturers
Manufacturing of biological products needs strict as well as careful monitoring, quality control, and documentation of all aspects of the complicated process including regulatory as well as in house records. Among these, the documentation, regulatory formalities are time consuming and need a rigorous check. CliniExperts gives you all the support by helping you throughout the manufacturing process. Our professionals are here to assist you right from obtaining No objection certificate (NOC) to global clinical trial permission. To ensure complete client satisfaction, we also support our clients during post approval changes.
Marketing authorization from cdsco
- NOC for
Form 29 - Manufacturer
in India - Clinical Trial
(Phase 1, 2 & 3) - Obtain Form
29 from SLA - Market the
Biologicals - Obtain Market
Authorization From
CDSCO (Central)
NOC for form 29
NOC for form 29 is the checklist required for NOC to manufacture test batches for testing and analysis under form 29. The checklist includes eight points for screening which include name of manufacturer, name of drug (s), source of MSL/WSL, process flow, site plan for manufacture of subject drug, list of equipment and testing facility and details of technology transfer (optional, in case thereof). Besides, personal details of the responsible entity including name, qualification, and experience are also screened. CliniExperts provides cost effective, client friendly, regulatory compliant services in attaining NOC which is the major step to initiate the analysis of manufactured product.
Test License
To obtain the test license, a long list of documents and details are required to be submitted which includes covering letter, authorization letter (in original), application in the prescribed Form 29 and 30 along with prescribed fees, list of biologicals to be manufactured for testing/ analysis/ examination, details of pharmaceutical aids used, NOC, details of similar products sold in the market, therapeutic rationale with technical literature, standards to be used and analytic strategies to be used, etc. To obtain the test license, the application has to be submitted in a flawless manner so as to obtain the approval in one go. This needs expertise and experience in regulatory affairs as well. Our team is skillful and dedicated to obtain it in the best possible way. We provide all the forms, and assist the client in filing as well as filing the documents.
Post Approval Changes
As per Central Drugs Standard Control Organization(CDSCO) amended guidelines for post approval changes in biological products, filing of fresh new drug or manufacturing licenses is mandatory. No provision for automatic approval of post approval changes.
If the change modifies the product into a new drug (as per definition under rule 122E of the Drugs and Cosmetics Rules), the manufacturers have to apply for new drug authorization. In case of change in manufacturing premises, an additional product permission is required to concerned state licensing authorities, zonal offices or sub-zonal offices and Central Licensing Approval Authority (CLAA) as per requirements of Drug & Cosmetics Act and Rules. An essential fee accompanies the documents as well. Prior to amendment, the applicants used to consider the acceptance of approval application in case there was no revert within 30 days of submission of application from Drug Controller General of India (DCGI). However, the amendments have made it mandatory to apply a file for new drug application if a major quality change has been made. Such amendments havemade the regulations stringent and it becomes mandatory for clients to attain the approval for post changes. We, at CliniExperts, provide end to end support in obtaining approval and that too in a hassle free manner.
Marketing Authorization
Marketing authorization involves the process of reviewing and assessing the dossier to support a biological product for its marketing, licensing, registration, approval, etc.) to finalization of dossier by granting of a document. For manufacturing, the CDSCO guidelines documented for submission of application should be followed as per CDSCO guidance document for industry, 2008. This tedious filing of application updated knowledge and expertise which the team of CliniExperts is rich in.
Clinical Trial Permission (Phase 1, 2 & 3) & GCT
After the submission of information related to preclinical studies, an approval is required to conduct clinical trials. An application has to be submitted as per CDSCO guidelines 2008, along with quality related data comparing the biological product under test and a reference biologic. A detailed structure for pharmacokinetic studies including half-life, linearity of pharmacokinetic parameters, endogenous levels and diurnal variations of similar biologic under study(where applicable), conditions and diseases to be treated, route(s) of administration, and indications should be submitted. All details of pharmacodynamic studiesare also submitted along with the application including relevant pharmacodynamic marker(s) and response, efficacy of the reference biologic. The range of acceptance of test product should also be predefined andappropriately justified.GCT involves submission of an application including applicant’s details, product details and study details.CliniExperts provides support under one roof along with complete documentation, filing and approval services.
For Importer
The import of biologicals needs special attention so as to ensure its safety, efficacy and availability. CDSCO undertakes the authority to check and allow import of biologicals. To attain import of biologicals, an application (Form 8) has to be filled with an approval form (Form 10). Similar to manufacturing process, import also involves registration, getting import license, market authorization and clinical trial permission procedures. CliniExperts consists of a group of smart working professionals with skills and knowledge of regulatory writing. We cater end to end services for complete client satisfaction.
Registration Process
- Vaccine
Manufacturer - Conduct Clinical
Trial (Phase I, Phase
II and Phase III) - GCP and Ethical
Guidelines (by ICMR)
pprovals are required - Submit result to national
regulatory Authority
(NRA) For Approval - Marketing
Authorization (Form
45) from CDSCO - Application for Registration
(Form 41) and Import License
(Form 10) are submitted and
approval received - Conduct Phase IV Clinical
trials [Post marketing
Surveillance (PMS)/Periodic
Safety Update Report (PSUR)]
Registration
The registration and import permission for biologicals is undertaken by biological division of CDSCO department.For filing of application, CTD module is followed which includes submission of administration and legal information,overall summaries, quality information (chemical, biological as well as pharmaceutical), non-clinical information, and clinical information. To submit bulk of information related to a products is time consuming and a single error might lead to following the whole procedure again. Our team is there to help our clients in all the times in a friendly way. We work as a team and keep our clients updated with the status of the application journey.
Import License
The import license is granted by CDSCO. After the foreign manufacturer is able to obtain the registration certificate in Form 41, the distributor in India also needs an import license. To obtain the same, he has to apply for Import license in Form 8. After the grant of license, the distributor is allowed to clear custom affairs and import the product into the country. Our team supports its clients at each step, from obtaining the form to clearing custom issues.
Marketing Authorization
Market authorization is an essential step during import of products so as to ensure quality control. The process of reviewing the data related to the product, its analysis till the grant of approval takes time. We, CliniExperts, provide our clients glitch free services, that too at a faster pace so as to achieve goals as swiftly as possible.
Clinical Trial Permission (Phase 1, 2 & 3) & GCT
As per Form 44, an application for grant of permission to conduct of human (Phase I), exploratory (Phase-II) and confirmatory clinical trials (Phase-III) is important. DCGI is involved in approving an imported biological product to be tested on humans. Our team also assists is getting approval for conducting clinical trials on imported biological products, that too in a cost effective way.
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Subject Expert Committee’s Updates
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