Agile Regulatory

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2026-02-24 05:09:22

How CDSCO Online Simplifies Drug and Medical Device Approvals in India
India’s pharmaceutical and medical device industries are among the fastest-growing sectors in the world. Regulatory compliance is a fundamental requirement before any drug or notified medical device can be marketed in the country. The CDSCO online portal has emerged as a centralized digital solution that streamlines approvals and regulatory submissions. Regulatory Framework in India The...

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2026-02-23 05:27:55

Complete Guide to MD 42 License for Medical Device Import in India
The MD 42 License is a mandatory registration required for importing medical devices into India. Under the regulatory framework of the Central Drugs Standard Control Organization (CDSCO), all notified medical devices must obtain proper authorization before being marketed or distributed in the country. The MD 42 license is specifically issued to authorized agents of foreign manufacturers who...

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2026-02-20 05:33:09

AD Code Registration on ICEGATE Made Simple
In today’s fast-paced trade environment, businesses need to ensure that import-export operations are seamless and compliant. One of the key steps in this process is AD Code Registration on ICEGATE. ICEGATE, the Indian Customs Electronic Gateway, provides a reliable platform for all importers and exporters to manage their regulatory requirements digitally. An AD Code, or Authorized Dealer...

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2026-02-20 05:28:06

RNI Registration Online: A Modern Publisher’s Roadmap
For journalists, editors, and aspiring publishers, securing official registration from the Registrar of Newspapers for India (RNI) is a foundational step in establishing and sustaining a credible publication in India. With the advent of digital governance, RNI registration has transitioned seamlessly to online platforms, offering simplicity, transparency, and nationwide reach. Understanding RNI...

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2026-02-19 06:34:26

How to Obtain a CDSCO License in India – Step-by-Step Regulatory Overview
In India, pharmaceutical and medical device businesses must obtain approval from the Central Drugs Standard Control Organization (CDSCO) before commencing operations. CDSCO acts as the national regulatory authority and ensures that drugs and medical devices available in the market meet prescribed safety and quality standards. The licensing framework is governed by the Drugs and...

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2026-02-17 05:40:53

Complete Guide to Getting a Digital Certificate for ICEGATE
In today’s fast-paced international trade environment, compliance and security are critical. Businesses engaged in import and export activities must ensure seamless documentation and secure electronic communication with customs authorities. One essential requirement for this process is a digital certificate for ICEGATE. ICEGATE, officially known as the Indian Customs Electronic Gateway,...

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2026-02-17 04:55:36

BIS Certification – Ensuring Safety, Quality, and Market Access
In India, the BIS Certificate is a benchmark for product quality and safety issued by the Bureau of Indian Standards (BIS). The certification acts as proof that a product meets the rigorous standards set by the government, ensuring consumer protection and compliance with statutory regulations. For businesses, obtaining BIS certification is often a legal requirement, especially for products like...

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2026-02-16 06:40:15

Step-by-Step Process for CDSCO Medical Device Import License
The Indian healthcare industry is expanding rapidly, attracting global medical device manufacturers. To legally import and distribute medical devices in India, businesses must secure a CDSCO Medical Device Import License from the Central Drugs Standard Control Organization. Understanding the Regulatory Framework Medical devices in India are regulated under the Medical Devices Rules, 2017....

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2026-02-14 07:17:14

Why Shop and Establishment License Registration in Delhi is Essential for Businesses
Starting a business in Delhi requires compliance with various legal formalities, and one of the most important registrations is the Shop and Establishment License Registration in Delhi. This license is mandatory for businesses operating within commercial establishments, including shops, offices, restaurants, and service centers. The Shop and Establishment Act regulates working conditions,...

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2026-02-13 06:10:24

Haryana Pollution Control Board Consent (CTE & CTO) – Complete Guide for Businesses
Starting or operating an industrial unit in Haryana requires environmental clearance from the Haryana State Pollution Control Board (HSPCB). The two primary approvals required are Consent to Establish (CTE) and Consent to Operate (CTO) under the provisions of the Water Act, 1974 and the Air Act, 1981. These consents ensure that industries comply with environmental norms and pollution control...

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2026-02-12 10:15:10

Understanding GJEPC Membership and Certificate Registration
The GJEPC Certificate Registration is a crucial certification for businesses operating in the gem and jewellery sector in India. Issued by the Gem & Jewellery Export Promotion Council (GJEPC), this certification allows companies and exporters to participate in international trade shows, receive government export benefits, and enhance credibility with global buyers. As India remains...

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2026-02-12 07:19:59

Understanding Revised Schedule M in Pharmacy – Key Updates and Compliance Requirements
The revised Schedule M in pharmacy is a significant regulatory update introduced to strengthen Good Manufacturing Practices (GMP) for pharmaceutical manufacturers in India. Schedule M, under the Drugs and Cosmetics Rules, 1945, lays down the requirements for premises, plant, equipment, and quality control systems for manufacturing drugs. With rapid advancements in pharmaceutical technology and...

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