Regulatory Intelligence And Strategy

With our years of expertise, collaborations and strong network of industry contacts, we provide insightful analysis of Indian regulatory scenario for Pharmaceutical, Food, Nutraceutical, Cosmetic, Medical Device, Diagnostic Kits, Biologicals and Vaccine industry. We know our homework well.

Product analysis and feasibility

We do a thorough product analysis and analyze the category for filing the product as per the regulatory framework on behalf of the client.

The regulatory scenario of the country has a strong influence on the approval of any new product. It is therefore necessary to be aware of the latest updates and new regulations or updates. Our strong roots in the industry and professional guidance provide you with the know-how of the updated guidelines and regulations facilitating the filing of appropriate documents for hassle free approvals.

We can act as an authorized agent/registration holder on your behalf for speedy import and market entry of your products.

The application checklist for different products is different as per the guidelines and is mandatory to be fulfilled for successful submissions. We provide assistance in compiling all the necessary documents and their validation as per national/state/district guidelines.

With our team of experts, the slightest details and updates as per the regulations are monitored and communicated to the client for labeling compliance minimizing the chances of queries.

We help our clients throughout the process of regulatory procedures providing step by step hand holding support for successful submission.

The timelines for submission of the application are well communicated to our clients. We assist in timely query responses to our clients filing the appropriate quality documents, reducing the chances of rejection.

Distribution Pathway is a combination of right Distributor Identification and Distribution Point. Our industry vantage point enables us to provide assistance to the importers for identification of distributors with strong networks,ensuring the best distribution and sales of their products to reach their target consumer audience.

Any post marketing changes on the products are notified to the regulatory authorities as per the formats applicable on behalf of our clients. We are in collaboration with Pharmacovigilance companies and can help clients monitor the effects of medical drugs in post approval marketing. We also write and review the Periodic Safety Update Report (PSUR) and Adverse Drug Reaction (ADR) reports for our clients enabling them to submit the data to regulatory authorities in India.

Authorized Agent/ Registration Holder Support

Foreign companies with no local presence trying to venture in India need to appoint an Authorized Agent/ Registration Holder. Holding a valid licensein Form 20B; 21B or renewal license in Form 21C, we can serve as an Authorized Agent/Registration Holder and be your in-country representative for end to-end registration processes including liaising with the regulatory authorities as CliniExperts Holds wholesale license in Form 20B and 21B.

Global Manufacturers

Post registration regulatory support

With years of regulatory roots, we provide post registration regulatory support to our clients. These include but are not limited to re-registration, renewal of license, PSUR, ADR reports, pharmacovigilance, distributor identification, regulatory compliance of labels as per new guidelines, complaint handling, query responses, product recall support, liaison with regulatory agencies. etc

In collaboration with Pharmacovigilance companies, we help our clients monitor the effects of medical drugs and devices after approval and post marketing. It helps in the identification and evaluation of previously unreported adverse reactions which need to be reported to the concerned authorities as per requirements.

Indian agent must possess a valid wholesale license (Form 20B, 21B & 21C) to be an Authorized agent/Registration Holder. We hold a valid wholesale license and can act as an authorized agent/registration holder on your behalf. Our years of experience in successful imports of products for our clients has given us valuable insights into the licensing industry which we bring to the table for our clients.

We help our clients file for re-registration of their products well before the prescribed time so that the license or registration certificate may stay valid and doesn’t expire.

We help our clients obtain the Import License for Import swiftly by filing the acceptable documents to the regulatory authorities enabling speedy market entry.

Form 9 is undertaking for authorization of Indian agent or of manufacturer or registration holder and is to be submitted along with application for an Import License in Form 8 to obtain Form 10. It is required to be notarized and authenticated from the Indian Embassy of the country of origin. In case of Indian agent it won’t require attestation. We provide services as an authorized agent and also support our clients in notarization of documents from different Embassies in India.

Distributor Identification

Our distributor identification services enable our clients to succeed in the Indian market for successful launch of the products. Identifying the right distribution channel to reach out to your customer is a job half done.

Distributor Identification

Advisory Service

We hand hold our clients in providing targeted solutions based on their requirements. These services are handled by our experts having years of experience in this field.

Business Plan

We believe that our clients should know all the required details of market and competitors before drawing a strategy to enter a particular market. We provide a business plan that includes all the relevant details from disease, its prevalence to available therapeutic regimen, competitors, therapy positioning and likely pricing and volumes.

Licensing

We undertake both In-Licensing and Out-Licensing thus helping our clients to expand their geographical reach.

Identification of Distributors and Companies

The right partner company is the key to succeed in any market. Our in depth knowledge of the market and excellent networking with decision makers in the potential licensor organizations, helps us to provide RIGHT TARGET.

Commercial Agreement

We assist our clients in negotiations and completing the deal till the final commercial agreement is signed.

Distribution Point

We provide a single window distribution point for our clients along with import and warehousing facilities, distribution channelization, invoicing and record maintenance services in India.

Single window
distribution for india
We act as a stock point for International companies. All products are meticulously stocked as per the requirements and in compliance with the standards.
import and
warehousing
We provide end to end services for import, clearance and warehousing of products. This brings confidence to our clients that there will be hassle free import and products are in safe hands.
distribution
within india
We are networked with the best in line logistic companies to ensure timely delivery of products to different distributors across the vast geographical span of India.
invoicing and
record maintenance
We understand the importance of maintaining all records for operational and legal purposes. We employ the latest technology to ensure efficiency and detailed record keeping with necessary backups wherever needed to prevent any data loss.

WE OFFER REGULATORY SOLUTIONS TO:

DRUGS

FOOD

COSMETICS

MEDICAL DEVICE

DIAGNOSTIC KIT

BIOLOGICALS

PESTICIDE AND INSECTICIDE

CRO

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Regulation/Guidelines

Legal Metrology – Importer, Manufacturer and Packaging Registration

The Directorate of Legal Metrology is a separate government wing under the Ministry of Consumer Affairs, Food and Public Distribution. The Legal Metrology department looks after the norms and regulations related to the measurements and weights of measuring devices and other products imported/manufactured or sold in the Indian market. According […]

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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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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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Regulation/Guidelines

Coronary Stents are Now Included in the National List of Essential Medicines: Its Impact on Prices, Availability, and Healthcare

  National List of Essential Medicines The National List of Essential Medicines (NLEM), 2011, has been reviewed and revised by the Core-Committee constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India. The committee has formulated a new list as per the inclusion and exclusion criteria. The […]

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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

CLINICAL TRIAL

It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process.

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Insight

MEDICAL DEVICE REGISTRATION IN INDIA

Medical device industry is still nascent in India, most devices are manufactured globally and imported

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Insight

Draft Guidelines on Similar Biologics, 2016

Medicinal products which are mainly composed of living tissues or cells are called Biologics

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Insight

FSSAI Draft Norms for E-Commerce FBO’s

To ensure safety FSSAI has come up with draft norms for e-commerce FBO's. It is now mandatory to obtain licenses for all online Food Businesses and supply chain

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