Navigate Regulatory Compliance with Confidence
Globallex Compliance provides multi-industry regulatory support across India and international markets, serving startups to multinational corporations with end-to-end compliance advisory.
- Regulatory strategy and gap assessment
- End-to-end registrations and licensing
- Import, manufacturing, and distribution compliance
- Ongoing advisory and remediation support
About Globallex Compliance
Globallex Compliance is a trusted regulatory and compliance advisory firm with a vision to simplify compliance, build trust with consumers, protect public health, and enable sustainable business growth.
We partner with companies ranging from early-stage startups to multinational corporations, providing clear regulatory guidance across pharmaceuticals, medical devices, cosmetics, food safety, manufacturing, and trade compliance.
Why Choose Globallex Compliance
What sets us apart in the regulatory compliance landscape
Regulatory Expertise
Our team comprises experienced regulatory professionals, legal consultants, technical experts, and industry veterans who bring deep domain knowledge to every engagement.
End-to-End Compliance
From initial assessment, documentation, and filings to government coordination and post-approval support, we manage every step of the compliance journey.
Transparent Processes
We maintain clear timelines, transparent communication of government fees and professional charges, and provide regular status updates throughout the process.
Industry-Specific Knowledge
Deep expertise across sectors including pharmaceuticals, medical devices, cosmetics, food, manufacturing, and trade compliance ensures precision in every service.
Our Comprehensive Services
Globallex Compliance offers a wide range of regulatory and compliance services tailored to different industries, business models, and jurisdictions.
Medical Device Registration
CDSCO registration for medical devices across all risk classes (A, B, C, D) for manufacturers and importers.
IVD Medical Device Registration
Registration of In Vitro Diagnostic devices with CDSCO, covering all IVD classes and categories.
Cosmetic Registration
Registration and licensing of cosmetic products under CDSCO for import and domestic manufacturing.
Drug License
Licensing for manufacturing, sale, and distribution of drugs under the Drugs and Cosmetics Act.
MD-42 Registration
Registration of notified medical devices under Form MD-42 for devices listed in the CDSCO schedule.
EPR Registration
Extended Producer Responsibility registration for managing plastic, e-waste, and packaging waste.
BIS Registration
Bureau of Indian Standards registration and ISI mark certification for mandatory product standards.
FSSAI Registration
Food safety licensing and registration under FSSAI for food businesses across all categories.
Legal Metrology
Compliance with Legal Metrology Act for packaged commodities, weight and measure declarations.
WPC/ETA Approval
Wireless Planning and Coordination approval and Equipment Type Approval for telecom equipment.
Sanitary Import Permit
Import permits for products of animal origin and related health clearances.
Animal Husbandry Approvals
Approvals related to animal-origin products, livestock feed, and veterinary products.
MSME Registration
Udyam Registration for Micro, Small and Medium Enterprises under the MSME Development Act.
Shop & Establishment Registration
Registration under state-specific Shops and Establishments Acts for commercial premises.
CDSCO Dual Use NOC
No Objection Certificate from CDSCO for products classified as dual-use (drug-device or cosmetic-drug).
Trademark Registration
Registration of trademarks, brand names, and logos under the Trade Marks Act, 1999.
Attestation and Notarization
Document attestation, apostille, and notarization services for regulatory and legal submissions.
Trade License
Trade license registration under state-specific Shop and Establishment Acts for retail and wholesale businesses.
Market Standing Certificate
Market Standing Certificate from state authorities for medical device, drug, and cosmetic distributors.
Non Conviction Certificate
Non-Conviction Certificate from police authorities required for regulatory compliance and business registration.
Free Sale Certificate
Free Sale Certificate from country of origin for pharmaceutical, medical device, and cosmetic exports to India.
GeM Registration
Government e-Marketplace (GeM) registration for selling products and services to government departments.
GST Registration
GST registration under the Goods and Services Tax Act for businesses with turnover above threshold.
IEC Certificate
Import-Export Code (IEC) certificate from DGFT for businesses engaged in international trade.
How We Work
Our structured process ensures efficient and transparent compliance
Assessment
We begin by understanding your business model, products, target markets, and applicable regulatory requirements to create a compliance roadmap.
Documentation
Our team identifies and prepares the required technical, legal, and quality documents, ensuring accuracy and completeness for submission.
Filing
We prepare and submit applications, forms, and dossiers to the relevant authorities through official portals and channels.
Government Coordination
We follow up with regulatory authorities, respond to queries, provide clarifications, and coordinate until your application is processed.
Approval & Support
We support you until approval is granted and continue to assist with ongoing compliance, renewals, and amendments as needed.
Industries We Serve
Specialized compliance solutions for regulated industries
Pharmaceuticals
Drug approvals, licensing, import compliance, labelling, and quality management for pharmaceutical businesses.
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Medical Devices
CDSCO registrations, risk-based classification, import and manufacturing approvals for medical devices and IVDs.
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Cosmetics
Cosmetic registration, safety and claims compliance, labelling requirements, and import clearances.
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Food & Beverage
FSSAI licensing, food safety standards, labelling compliance, and nutraceutical regulations.
ExplorePartner with Compliance Experts
Let our experience work for you. Contact Globallex Compliance today to discuss your regulatory needs and discover how we can help your business achieve seamless compliance.
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