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.
For Importers
India has developed at a staggering rate as an economy. Hence the demand for medical care equipment has skyrocketed in the recent years. The new medical rules have classified all the existing diagnostic kits, including those which were earlier not classified. Filing an application for obtaining an import license is a simple single step process now. The process has been simplified to expedite the process and ensure proper availability of diagnostic kits in the country. The New Medical Device Rules allow multiple importers of a single diagnostic kit which was forbidden earlier. Although, each importer has to file a separate application for each diagnostic kit being imported.
Marketing authorization from cdsco
NOC for Form 29
Manufacturer in India
Clinical Trial (Phase 1, 2 & 3)
Obtain Form 29 from SLA
Obtain Market Authorization From CDSCO (Central)
For Importers
India has developed at a staggering rate as an economy. Hence the demand for medical care equipment has skyrocketed in the recent years. The new medical rules have classified all the existing diagnostic kits, including those which were earlier not classified. Filing an application for obtaining an import license is a simple single step process now. The process has been simplified to expedite the process and ensure proper availability of diagnostic kits in the country. The New Medical Device Rules allow multiple importers of a single diagnostic kit which was forbidden earlier. Although, each importer has to file a separate application for each diagnostic kit being imported.
Registration Process
Registration
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
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
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
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.
Trial
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.
Permission (Phase 1, 2 & 3) & GCT
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.
Insight
India Champions e-Governance for Pharma Industry
National e-Governance plan (NeGP), launched in 2006 as initiative that Government of India has implemented to make all government services accessible online.
Drug | DCGI | Ethics | Committee | DGFT | ICMR | NeGP | MoHFW | MoCI | CDSCO | India | India Regulatory Services
Insight
Sugam Portal – CDSCO Sugam Registration for Online Application
Indian Government has chosen to join the foray and ride the digital wave through SUGAM, launched on 14 November, 2015
Drug | DCGI | India | India Regulatory Services
Insight
Sugam Portal – CDSCO Sugam Registration for Online Application
Indian Government has chosen to join the foray and ride the digital wave through SUGAM, launched on 14 November, 2015
Drug | DCGI | India | India Regulatory Services
Registration For Non-Notified In Vitro Diagnostic in India
All non-notified In-vitro Diagnostic (IVDs) medical devices, excluding those already under the notified category of the medical device need registration with the CDSCO.
Importer | Regulatory Body: CDSCO
Test License to Import In-vitro Diagnostics in India in India – MD 16 & MD 17
The Central Drugs Standard Control Organization (CDSCO) has issued a notice stating that a small number of medical devices might be imported into India. The devices belonging to Class A, Class B, Class C, or Class D may be imported in small quantities to India based on Test License in Form MD-17.
custon-fontImporter | Regulatory Body: CDSCO