Services
Formula validation
Our experts validate the core formula within the framework of the target Iraqi MOH regulations and technical requirements via review the product data and advice on the actions that should be taken based on the applicable standards and regulations to enter a new molecule in the lists of National Committee for
– Drug Selection.
– Dosage form.
– Strength.
– Quality.
– Performance characteristics.
– Intended use.
– Route of administration.
– Combination product.
– Indication.
– Is the product a new or novel formulation.
– Collect & evaluate scientific data from a range of sources.
Product Classification
Classification of the product requires an understanding of the regulations to the competent authorities, for the supply of a medicinal product must classification firstly (Chemical drug, biology, Supplement, OTC, Medical Device, Cosmetics).
Label Validation
Noncompliance with the targeted market can lead to determinant consequences for both the product and the business so must ensuring the mockups, trade names, products’ labels are in line with the regulations and standards meet to the regulations of Iraqi MOH to ensure the highest mitigation of possible risks.
Technical Translation
Our technical translation service covers the following:
– Translation of leaflets, brochures & labels from English into Arabic by using technical terms in line with the local regulations and common practices.
– Translation of the laws, news , technical & standards.
– Translation of the registration documents for legalization purposes.
Early Updates & Warnings
Providing solutions for solving non-conformity and compliance issues depending on the nature of the crisis we identify the problem, analyze possible solutions, and perform negotiations until we find a suitable solution for both the authority and our clients depending on the situation we can either accommodate for a long term or a short term solution & alert you to potential changes of any regulations, policies, or legislation that might apply high risks on your product within 72 hours, our updates allow you to prepare for it, turn it into opportunities and/or avoid losses.
Choosing the Appropriate Regulatory Pathway
Prepare the documents of the importing license of products , narcotics , medical devices & cosmetics to submission & follow up the body authorities to get approval of MOH:
– Primary Registration
– Private Registration
– Ordinary Registration
Testing Quality Control
Submission & follow the products to pass the testing of QC lab & ensure the results meet to the reference specification in the public & private sectors.
Variations – Post Marketing
Submit the variations to keep the marketing authorization up to date included all the changes made in the dossier of an authorized product after its initial registration. They may concern administrative changes, Quality changes, Safety/Efficacy changes, or Vigilance changes when the marketing authorization is granted by the competent authorities, commercialization of the medicinal product can begin, but through variation post-approval amendments will continue to be submitted by the regulatory affairs team, to ensure the dossier being approved by regulators is always updated ( add production line , change the MAH , change the trade name , change the price, update in specification, update the leaflet , development the formula , extension of shelf life ).
Import Permission
– Prepare the documents of importing license of products, Narcotic , Medical device & Cosmetic.
– Submission & follow the body authorities to get approval for importing.
– Follow up the commerce ministry & customs clearance .
Tender
– Follow-up the tenders of Kimadia to submit , prepare the offers & negotiate in front of the organizations or consultant committees in the public sector market for the whole of Iraq & all necessary correspondences with governmental authorities.
– Conducting survey studies of the products & companies competitive in the Iraqi market .