Pharma Export — Service 04
Regulatory & Documentation Support for Global Markets
Exporting pharmaceuticals requires navigating complex regulatory frameworks in every destination country. We provide comprehensive support to ensure your products meet all compliance requirements.
Discuss Your RequirementsWhat We Handle
Our Regulatory Services
Product Dossier Preparation (CTD Format)
Complete CTD (Common Technical Document) dossier compilation for product registration in regulated markets.
Free Sale Certificate (FSC) via CDSCO
Coordination of FSC issuance through India's Central Drugs Standard Control Organisation — required for export to many countries.
Country-Specific Product Registration Support
Guidance and documentation support for product registration in your target market — Kenya, UAE, Nigeria, UK, EU, and more.
Certificate of Pharmaceutical Product (COPP)
COPP coordination — issued by Indian regulators, required by many importing countries as proof of product approval in India.
Artwork & Labeling Compliance
Multi-language labeling, country-specific artwork requirements, and compliance review — including Arabic for Middle East markets.
Export Documentation (Complete Set)
Commercial Invoice, Packing List, Bill of Lading, Certificate of Origin, Insurance Certificate, COA — every document ready for customs.
Markets We Support
Global Regulatory Coverage
USA
FDA compliance guidance, ANDA/DMF references, facility registration support.
United Kingdom
MHRA requirements, MA (Marketing Authorisation) support, post-Brexit compliance.
European Union
EMA pathways, CEP for APIs, EU-GMP compliance, qualified person requirements.
Kenya
PPB registration support, Free Sale Certificate coordination, Kenyan labeling requirements.
UAE
MOH registration, authorized agent coordination, Arabic labeling, HAAD compliance.
Nigeria, South Africa & More
NAFDAC (Nigeria), SAHPRA (South Africa), and other African market regulatory pathways.
Discuss Your Regulatory Requirements
Tell us your target market and product type — we'll outline what's required and how we can support you through the process.
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