Extensive Regulation
Relevant authorities, authorisations and the sector's regulatory framework.
- Pharmaceutical Raw Materials
- Human and Veterinary Medicines
- Medical Devices and Supplies
- Biotechnology Products
- Healthcare Supply Chain
SECTORS› PHARMACEUTICALS & HEALTHCARE
Highly regulated.
Critical foreign trade decisions.
With extensive regulation, complex products and critical supply chains, pharmaceuticals and healthcare is one of the most sensitive sectors for foreign trade and compliance. INSPEC provides correct, compliant and sustainable solutions for classification, authorisations, regulatory and customs processes involving products, raw materials and production inputs.
SECTOR-SPECIFIC FOREIGN TRADE RISK CHAIN
PRODUCT
Scope and characteristics of human and veterinary medicines, raw materials and healthcare products.
TECHNICAL DATA
Analysis of product formulations, technical files and specifications.
CLASSIFICATION
Correct tariff identification and classification based on technical specifications.
AUTHORISATION / REGULATION
Analysis of import authorisations, restrictions and sector legislation.
VALUE
Correct calculation of customs value and additional financial obligations.
IMPORT
Customs processes and appropriate regime selection.
SUPPLY CHAIN
Critical supply chain structures and continuity risks.
COMPLIANCE
Integrated process management and sustainable compliance.
PRODUCT INTEGRITY AND COMPLIANCE CHAIN
PRODUCT INTEGRITY
(Product Integrity)
REGULATORY REQUIREMENT
(Regulatory Requirement)
TRADE REQUIREMENT
(Foreign Trade Requirements)
CONTROL
(Control)
TRACEABILITY
(Traceability)
KEY SECTOR CHARACTERISTICS
Critical products,
complex regulations.
The pharmaceuticals and healthcare sector requires specialist foreign trade and compliance expertise due to extensive regulation, frequent regulatory changes, product and raw material variety, import authorisations and critical supply chains.
The sector covers a broad range including human and veterinary medicines, active ingredients, excipients, medical devices and supplies, diagnostic kits and biotechnology products, with different technical, regulatory and foreign trade requirements for each group.
Critical Supply Chains
Sourcing of raw materials, active ingredients and excipients.
Product and Raw Material Variety
Chemical, biological, herbal and advanced technology products.
Classification Sensitivity
Correct tariff identification based on technical specifications.
Traceability and Record Management
Serialisation, recording, reporting and audit requirements.
KEY AREAS OF EXPERTISE FOR THE SECTOR
Tariff & HS Classification
Correct classification and tariff treatment of pharmaceutical and healthcare products.
Origin & Free Trade Agreements
Determining origin and using free trade agreements.
Authorised Economic Operator (AEO)
AEO conditions, internal control and sustainable compliance structures.
Trade Policy Measures
Analysis of anti-dumping, safeguard measures, import restrictions and surveillance practices.
Investment & Export Incentives
Eligibility analysis and support mechanisms for investment, R&D and export incentives.
Risk & Compliance Management
Regulatory compliance, record management and sustainable compliance structures.
OUR AUDIT APPROACH
Test compliance end to end
for critical products and transactions.
We test the full process, including product classification, authorisation and regulatory processes, customs regimes, valuation, related-party transactions and record management, identifying risks and providing objective findings.
Our Audit ServicesOUR ADVISORY APPROACH
Manage regulatory and foreign trade
decisions from one perspective.
We assess classification, regime, supply chain, investment and incentive options against your product structure and regulatory requirements, developing practical and sustainable foreign trade solutions.
Our Advisory ServicesOUR TEAM
Meet our team.
Let us assess your pharmaceuticals and healthcare sector needs together.
THE RIGHT SOLUTION FOR YOU