Services of Registration and Re-Registration
We offer comprehensive registration and re-registration services for all facilities engaged in the manufacturing of cosmetics, pharmaceuticals, nutritional supplements, medical supplies, and medical devices. We guarantee that every service rendered adheres to the legal and regulatory requirements that are in effect in Iraq.
Services of Registration and Re-Registration of products
We provide registration and re-registration services for pharmaceutical products, dietary supplements, and herbal products, ensuring their legal and smooth marketing in the Iraqi market.
Medical Supplies and Devices Classification Service
Medical supplies and devices are categorized following regulatory requirements to ensure compliance with health standards.
Services for Pharmaceutical Declarations
Our objective is to approve pharmaceutical products of every type by implementing precise and expeditious protocols that guarantee the products’ prompt entry into the market.
Services of Import permits
We assist our clients in acquiring the import authorizations required by the Ministry of Health, thereby guaranteeing the lawful and seamless transportation of goods.
Provision of importation licenses
The import licensing services we offer are administered by the Ministry of Trade, thereby streamlining the importation procedure for medical products into Iraq.
Services for shipping and customs clearance
Shipping and customs clearance services are offered for all medical products, accompanied by diligent follow-up to guarantee the secure and prompt arrival of dispatches.
Customs release follow-up and subsequent monitoring
To ensure the unimpeded flow of products, we ensure compliance with customs exit departments by undertaking the required approvals and follow-up on cargo arriving from border crossings.
Lab analysis for medications and supplements at NCDCR
To ensure the quality and safety of products, we conduct follow-ups and finalize the examination of pharmaceuticals, nutritional supplements, botanical supplements, and medical devices in drug control laboratories.
Provide separation columns and standard materials
For laboratory inspections, we furnish separation columns and standard materials, thereby guaranteeing the precision and dependability of analyses.
Services in translation and certification
We ensure that corporate documents adhere regulatory requirements by providing translation and attestation services; this facilitates official transactions and processes.
Bioequivalence studies
We conduct bioequivalence studies for pharmaceuticals to guarantee their adherence to the criteria set forth by the Iraqi Ministry of Health. This enables the registration and subsequent marketing of the products on the Iraqi market.
Executing contracts with Kimadia
By monitoring and carrying out the contractual obligations of the General Company for Marketing Medicines and Medical Appliances (Kimadia), we guarantee the implementation of contracts in a streamlined and effective manner.
Contracts with the Ministry of Health and Market Research
We offer market research services to the private sector, as well as oversee the implementation of contracts submitted by the Ministry of Health. This enables us to gain a deeper understanding of market demands and improve our ability to meet them.
Pharmacovigilance consulting services
Our company provides comprehensive third-party pharmacovigilance services to ensure regulatory compliance and patient safety. We specialize in adverse event reporting, risk assessment, literature monitoring, safety data management, regulatory submissions, audits, and global PV support. Additionally, we offer expert consulting, training, and medical review to enhance pharmacovigilance processes for pharmaceutical companies
ISO 9001 certification
Our company offer ISO 9001 certification support, internal audits, CAPA implementation, performance monitoring, and management review assistance. Our expertise ensures alignment with international standards, including WHO, EU GDP, and FDA regulations, facilitating continuous improvement and streamlined quality management systems to enhance operational efficiency and regulatory compliance.
QA consulting services
Our company provides comprehensive Quality Assurance (QA) and Compliance Consulting Services tailored for pharmaceutical companies to ensure regulatory adherence, operational excellence, and product safety. We specialize in documentation management, change control, batch record review, Good Distribution Practice (GDP) audits, warehouse and logistics compliance, and risk management.
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