INTRODUCTION

BIOLOGICALS 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 the detailed filing of the dossier as required and do rigorous and careful verification so as to successfully file the application in one go.

Two types of Biologicals Regulatory Services

Biological regulatory service
DOCUMENT REQUIRED
Following documents are required with application form :
  • Covering Letter clearly mentioning the purpose of test license for Developmental/Preclinical studies/Clinical Studies.
  • Name of the Drug/Drugs
  • Source of MSL/WSL with their Biosafety Level requirements.
  • Details of the proposed site: New/Existing.
  • Site plan for manufacture of proposed Drugs.
  • List of existing drugs manufactured in the proposed facility (with their BSL requirements), if any.
  • Details of the manufacturing license (with product permissions) for the proposed site, if any.
  • Details of previous joint inspection of the proposed site 1) Date 2) Purpose 3) Compliance status. (Proposed site shall also include details of particular manufacturing Blocks which was inspected earlier along with the name(s) and type of product(s) produced in this particular manufacturing Block)
  • Process Flow
  • List of equipment and testing Facility
  • Details of the manufacturing license (with product permissions) for the proposed site, if any.
  • If Technology Transfer, Details thereof.
  • Name, Qualification experience of personal responsibility for manufacturing & testing of trial batches
  • Undertaking by applicant

FOR 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.
PROCESS
01.

NOC for form 29

02.

Test License

03.

Post Approval Changes

04.

Marketing Authorization

05.

Clinical Trial Permission
(Phase 1, 2 & 3) & GCT

Download Forms

Download sample License

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 the 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 a change in manufacturing premises, 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.

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.
PROCESS
01.

Registration

02.

Import License

03.

Marketing Authorization

04.

Clinical Trial Permission
(Phase 1, 2 & 3) & GCT

Download Forms

Download Application form
Download sample License

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.
WHY US ?

Point 1

We provide customized solutions with No Hidden cost and  Job tacking (updates)

Point 2

We are famous for our fast delivery, Easy Documentation & value for money

Point 3

We are the company with 10+ years of experience

TIMELINE

If the application is complete in all respects and information specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41
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    FAQs

    What is a biological product?

    Biological products, like other drugs, are used for the treatment, prevention or cure of disease in humans. In contrast to chemically synthesized small relative molecular mass drugs, which have a well-defined structure and may be thoroughly characterized, biological products are generally derived from living material–human, animal, or microorganism– are complex in structure, and thus are usually not fully characterized.

    Section 351 of the general public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of citizenry .” FDA regulations and policies have established that biological products include blood-derived products, vaccines, in vivo diagnostic allergenic products, immunoglobulin products, products containing cells or microorganisms, and most protein products. Biological products subject to the PHS Act also meet the definition of medicine under the Federal Food, Drug and Cosmetic Act (FDC Act). Note that hormones like insulin, glucagon, and human somatotropin are regulated as drugs under the FDC Act, not biological products under the PHS Act.

    What are the requirements for licensing a biological Device?

    Issuance of a biologics license may be a determination that the merchandise , the manufacturing process, and therefore the manufacturing facilities meet applicable requirements to make sure the continued safety, purity and potency of the merchandise .

    Among other things, safety and purity assessments must consider the storage and testing of cell substrates that are often wont to manufacture biologics. A potency assay is required thanks to the complexity and heterogeneity of biologics.

    How is the manufacturing process for a biological product usually different from the process for drugs?

    Because, in many cases, there’s limited ability to spot the identity of the clinically active components of a posh biological product, such products are often defined by their manufacturing processes. Changes within the manufacturing process, equipment or facilities could end in changes within the biological product itself and sometimes require additional clinical studies to demonstrate the product’s safety, identity, purity and potency. Traditional drug products usually contains pure chemical substances that are easily analyzed after manufacture. Since there’s a big difference in how biological products are made, the assembly is monitored by the agency from the first stages to form sure the ultimate product seems needless to say .