CDSCO Drug & Cosmetic Registration Support (India)
CDSCO registration support for drugs and cosmetics in India—dossier preparation, application filing, and regulatory guidance.
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Customs Documentation & HS Code Classification Advisory (India)
Accurate HS code classification and customs documentation to speed up import/export clearance in India.
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RCMC / Export Promotion Council Registration
Facilitate RCMC with relevant Export Promotion Councils and Commodity Boards for Indian exporters, end-to-end support.
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AQCS (Animal Quarantine & Certification Services) Documentation
Documentation support for AQCS certificates covering livestock, dairy and animal-origin exports from India.
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Customs EDI Filing & CHA Coordination
Handle EDI filing and coordinate with customs house agents for smooth import/export clearance.
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FDA Facility Registration & Renewal (Food, Drug & Cosmetic)
Register and renew FDA facilities for food, drug and cosmetic businesses in the United States, with accurate submissions.
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FDA Food Label Compliance & Nutrition Facts Panel Review
Ensure FDA‑compliant food labeling with accurate Nutrition Facts panels, claims and allergen statements for U.S. market entry.
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FDA Dietary Supplement NDIN & Pre‑Market Notification Support
Prepare and submit New Dietary Ingredient Notifications (NDIN) and related pre‑market documentation for supplements.
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FDA GRAS Notification & Self‑Affirmed GRAS Dossier
Develop GRAS notices and self‑affirmed GRAS dossiers to establish ingredient safety for the U.S. market.
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FDA Drug Establishment Registration & NDC Code Assignment
Register drug establishments and secure National Drug Codes (NDC) to meet U.S. regulatory requirements.
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FDA Cosmetic Product Listing & Label Compliance
List cosmetic products and ensure label compliance under U.S. regulations, including ingredient and warning statements.
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FDA Medical Device 510(k) Submission & FURLS Registration
Prepare 510(k) submissions and manage device registration in FDA’s FURLS system to enable U.S. commercialization.
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USDA/APHIS Import Permits (Plant & Animal Products)
Guidance to obtain USDA/APHIS permits for importing plant, animal and processed food products into the United States.
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Health Canada NHP License (NPN) Application
Secure Natural Health Product numbers (NPN) with complete dossiers and submissions to Health Canada.
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CFIA Nutrition Facts Table Review & SFCR License Support
Review nutrition facts tables and support licensing under the Safe Food for Canadians Regulations (SFCR).
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Health Canada OTC Drug DIN Application Support
Obtain Drug Identification Numbers (DIN) for OTC products through complete Health Canada documentation.
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Health Canada Veterinary Health Product (VHP) Registration
Register Veterinary Health Products with Health Canada via accurate documentation and submissions.
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FSANZ Packaging Claims & Country of Origin Label Review
Verify packaging claims and origin labeling to meet FSANZ and Australian Consumer Law requirements.
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TGA Complementary Medicine Listing (AUST L) Documentation
Assist with low‑risk therapeutic goods listing applications under TGA guidelines, including evidence and labeling.
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TGA Label Review for Therapeutic Goods
Ensure therapeutic goods labels meet TGA content, format and warning requirements.
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TGA BECON Import Permit Documentation
Prepare applications and documentation under Australia’s BICON system for permitted imports subject to biosecurity controls.
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