Drug Regulatory Services

Drug Regulatory Services

Comprehensive regulatory solutions for registering and marketing drug products

For Manufacturer

At CliniExperts, we help manufacturers overcome the barriers in preparing unambiguous dossiers for filing applications for various registrations. Experts from our team represent our clients at the NDAC/SEC meetings to obtain unanimous approvals and permissions. Our constant guidance, thorough follow up and other services like clinical trial management, medical writing, etc. enable our client to obtain successful registrations smoothly and apply for licenses.

Central – CDSCO

“Investigational new drug” means any new chemical entity or substance which is under investigation in a clinical trial to assess its safety and efficacy.

We help ease the manufacturer’s journey in the process of receiving approvals for new drugs under investigation that are waiting to be introduced in the Indian market.Read More

We provide comprehensive solutions for new formulations, API, FDCs, new indication for existing drug, new dosage form, modified release dosage form, veterinary products and for vaccines, recombinant Deoxyribonucleic Acid (r-DNA) derived products, living modified organisms, monoclonal anti-bodies, stem cells, gene therapeutic products and xenografts which are intended to be used as drugs. Read More

‘Subsequent new drug’ is not defined, but is an officially accepted term by CDSCO in the context of approval of new drug products of the same therapeutic class or of a different therapeutic class for a new indication, new strength, new pharmaceutical dosage form or new route of administration.

We have the best team of regulatory experts that will guide you throughout the entire process of obtaining the Subsequent new drug approval.Read More

The requirements for BE NOC are general in nature, however, depending on the nature of the drug, disease and studies, additional specific information may be required to be furnished by the firm.

The experienced team of seasoned problem solvers at CliniExperts provide the clients with end-to-end consultation on BE NOC requirements.Read More

If you have an exported product that needs a special code on label authorized by the Licensing Committee, we can obtain NOC for Special Code for our clients. The products include finished formulations, Bulk drug, Narcotic drug, Psychotropic substances, etc. Read More

The New Drug Advisory Committees (NDACs) renamed as Subject Expert Committee (SEC) evaluates the applications of clinical trials and new drugs. Their recommendations are reviewed by the Technical Review Committee (TRC) based on which the Clinical Trial and New Drugs get approval by CDSCO.

The CliniExperts team will set you sailing through all the queries and help you prepare for the SEC meetings. We also prepare the presentation and attend the SEC meetings on behalf of our clients easing out their process for speedy approval.Read More

Toxicity testing or safety testing is defined as the study of adverse effects of chemical and physical agents on biological systems. There are various types of toxicology studies which need to be performed as per the GLP and the guidelines laid down by CDSCO. CliniExperts is the right partner for all your Toxicological Study needs.Read More

Bioequivalence Studies is a method used to demonstrate comparative therapeutic equivalence between two drugs products providing an objective mean to assess the possibility of alternate use of two similar generic products. Our team will hand hold and guide you through any of your queries on the Bioequivalence Studies and help you conduct these studies with relative ease.Read More

We help our clients in obtaining Regulatory permission from DCGI to commence clinical trials for phases I, II and III, Test license and /export NOC from DCGI, Approvals, Notifications or No-objections for Protocol Amendments, Notifications of documents such as ICF, SAEs, etc. We at CliniExperts will guide you throughout the process and help get the necessary approval smoothly. Read More

Medical writing is an integral part at every stage of developing any therapeutic product. CliniExperts is a one stop solution for all your medical writing needs. Our services also include literature search and PSUR writing. Read More

Zonal – CDSCO

A Test license is issued for the purpose of examination, test or analysis of a drug in small quantities which is otherwise prohibited under section 10 of the D & C Act and Rules, 1945. This license is issued in Form 29 for Manufacturers from State Licensing Authority (SLA). We provide end-to-end consultation services to obtain Test License in a hassle-free manner. Read More

A manufacturer holding a valid license copy as per the Form-25 and Form-28 can obtain a No Objection Certificate (NOC) from Zonal/Sub Zonal offices of CDSCO for export purposes only for approved / unapproved new drug / banned drug in India. The process of obtaining these NOCs requires proper filling of documents. The process of obtaining the required NOCs can be eased by consulting a team of experts at CliniExperts. Read More

A Dual NOC is required for the import of drugs and items capable of dual use in pharma and non-pharma industry. The permission has to be obtained from the Zonal Offices of CDSCO. CliniExperts can guide you throughout the process for obtaining the NOC for drugs with dual use. Read More

State – FDA

For manufacturing of Allopathic drugs/products, a Manufacturing License is required as per D & C Act, 1940. To obtain a manufacturing license, filing of correct documents as per the State Licensing Authority (SLA) and/or Central License Approving Authority (CLAA) is required, whichever is applicable. At CliniExperts, our team of seasoned professionals guides you throughout the process and help you get the manufacturing license stress free. Read More

Test license in Form 29 is a license to manufacture drugs for the purpose of examination, testing or analysis of drugs. At CliniExperts, we guide you throughout the licensing process to file the appropriate documents for obtaining the license glitch free. Read More

A Wholesale License is required for sale or distribution of drugs in Form 20B & 21B or its renewal in Form 21C by the manufacturer (subsidiary office/representative of the parent company) or any others who want to sell, stock, exhibit or offer for sale or distribute drugs. It is issued by the State Licensing Authority (SLA) in India. CliniExperts understands the importance of obtaining licenses smoothly and timely.Our team of professionals will guide you meticulously throughout the process. Read More

Free Sale Certificate/ Certificate for Export/ Certificate to Foreign Governments is issued by a national regulatory authority of an exporting country based on national legislation confirming that the product is freely sold and is registered for use in the country. At CliniExperts, our knowledgeable team of experts guide you step by step throughout the process tight till the very end of obtaining the certificate. Read More

For Importer

With top notch strategizing skills and capabilities, we at CliniExperts assist some of the leading companies trying to venture in India scouting for newer opportunities for their pharmaceutical products. We provide assistance in all aspects of regulatory services which can be tedious if not known. Our in depth knowledge and market expertise helps them gain speedy market entry in India.

Pre – Marketing

To register a drug product in India and for post-market surveillance requirements, the exporting company must appoint an Authorized Agent. A distributor, direct subsidiary or an independent agent with a wholesale license can act as an authorized agent. We hold a valid wholesale license and can act as an Authorized Agent/Registration Holder for you helping you import your products in India. It helps you gain speedy market entry which is difficult without an experienced and capable authorized agent.Read More

Marketing authorization is given by CDSCO to different types of imported drugs. These drugs need to be registered along with their site of manufacture.An appropriate application is submitted to the CDSCO to receive import permission for the same. At CliniExperts, we hand hold our clients all the way tillthey obtain the Marketing Authorization smoothly.Read More

The Registration Certificate is issued under Rule 27A by CDSCO in Form 41 for registration of premises and drugs manufactured intended for import and use in India. At CliniExperts, our team of professionals will help you throughout the process of acquiring the Registration Certificate without any undue delays or unforeseen hiccups.Read More

An Import License is required for import, manufacturing, sale and distribution of drug in India. An application for an import license is made to CDSCO which grants the same on successful application. At CliniExperts, our team of professionals ensures that you obtain the Import license in minimal possible time with minimal effort.Read More

A Test license is issued for the purpose of examination, test or analysis of a drug in small quantities which is otherwise prohibited under Section 10 of the D & C Rules, 1945. This license is issued in Form 11 for Importer from Zonal offices. We provide consultation services to obtain Test License in a pre-designed and error-free manner. Read More

Post-marketing Services

The Rule 37 of Drug and Cosmetic Rules, 1945 governs the packing of patent or proprietary medicines and its import in India in containers intended for retail sale. A permission needs to be obtained in writing from CDSCO to import such medicines at least three months prior to the date of import. We at CliniExperts help you obtain this permission to facilitate the import of medicines for retail sale smoothly. Read More

The approval of registration certificate and import license of drugs are issued for specific time periods and are required to be renewed as per the D & C Act 1940 & Rules 1945. We at CliniExperts assist our clients in filing the required documents with appropriate information for obtaining hassle free renewal.Read More

Shelf life Extension is obtained from CDSCO post registration of product, when further stability testing on product establishes to have a shelf life exceeding than that mentioned on the label in the registration application. We, at CliniExperts, help you obtain the Shelf life Extension for your products filing the apt documents facilitating speedy permissions.Read More

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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.

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Insight

Summary of New Drug, New FDC and SND as per Drug and Cosmetic Act

Definitions of New Drug, FDC, SND and associated form

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Strategy

Global Licensing & Registration

Drug product registration and licensing in Europe, Africa, Asia, the Middle East and South America

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Strategy

Global Drug & Medical Device Regulatory Consulting

Global Licensing and Registration, Product Registration Process – a strategy that ensures optimum results, Dossier Preparation for Export and Registration, Writing & Review of- Summaries and Drug Master File

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Insight

Sugam – CDSCO Portal for Online Application

Indian Government has chosen to join the foray and ride the digital wave through SUGAM, launched on 14 November, 2015

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Feature

State FDA & Zonal CDSCO

Zonal Licences (East, West, North and South Zone), State Licenses

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News

Self-Assessment/Audit of Unit for GMP/GLP Compliance

For Manufacturer At CliniExperts, we help manufacturers overcome the barriers in preparing unambiguous dossiers for filing applications for various registrations. Experts from our team represent our clients at the NDAC/SEC meetings to obtain unanimous approvals and permissions. Our constant guidance, thorough follow up and other services like clinical trial management, […]

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Insight

Subject Expert Committee’s Updates

For Manufacturer At CliniExperts, we help manufacturers overcome the barriers in preparing unambiguous dossiers for filing applications for various registrations. Experts from our team represent our clients at the NDAC/SEC meetings to obtain unanimous approvals and permissions. Our constant guidance, thorough follow up and other services like clinical trial management, […]

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Insight

NDAC/MDAC/SEC

In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s (MDAC) to advise the CDSCO in making their decisions on approval of new drugs and global clinical trials.

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