Regulatory & Market Access

The power of possibilities

  comprehensive expertise can help you confidently interact with regulatory affairs authorities for different therapeutic area and package and present all the information necessary to allow regulatory authorities to make the right decision.
100% of approximately 150 submissions to the FDO have passed technical validation for registering IRC.
50+ DIAF and 1.5 million pages published (all document types, e.g., DIAF /pharmacoeconomic/CTD ).
70% of our regulatory professionals hold advanced degrees, with an average of more than 16 years of experience.


Regulatory Affair
The power of possibilities
EXIRHEALTH ’ comprehensive expertise can help you confidently interact with regulatory affairs authorities for different therapeutic area and package and present all the information necessary to allow regulatory authorities to make the right decision for passing registration prices

  • 100% of approximately 35 submissions to the FDO have passed technical validation for registering IRC.
  • 50+ DIAF and 30000 pages published (all document types, e.g., DIAF /pharmacoeconomic/CTD ).
  • 70% of our regulatory professionals hold advanced degrees, with an average of more than 16 years of experience.


Anticipate what Iran payers want
Payers are pushing for more evidence of value, bringing a new level of scrutiny to formulary and reimbursement decisions. Working together at the earliest stages of your commercial planning, ESS can help you tailor your value proposition and pricing to local and national health plans. Our team of national account managers works with the majority of commercial plans that influence most of the prescriptions written in the Iran. As Iran ministry of health regulatory requirements keep evolving, we’re here to help you increase your chances of regulatory approval.

The power of possibilities
Put our relationships to work for your product. We’ve worked with a majority of all payers – including top managed care organizations, national welfare minister. To learn more, contact our regulatory team.

ExirHealth regulatory team includes over 6 professionals, to help you navigate regulatory requirements throughout your product’s development lifecycle. Comprehensive expertise and capacity to help you gain regulatory approval. On the road to regulatory approval, you invest years and millions of dollars in drug development. Don’t let the complexities of filing across multiple countries delay your launch. With ExirHealth integrated cross-functional expertise we can help increase the probability of successfully registering your products.
The proof of our success ? 87% of ExirHealth Product registration submission to MOH has passed technical validation and registered in IDL in past 5 years.
•    Having sufficient knowledge of drug registration rules & regulations for registration of products
•    Adequately capability of registering new products in the Drug National List
•    Closed relation with MOH to the established and proven commitment & credibility
•    Well knowledge of the drug; raw material and food supplement approval process and registration bureaucracy
•    Submitting registration documents to MOH with a great speed without any delay subsequently pursuing the case, in MOH continuously to receive the needed licenses.

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