SERVICES

Regulatory Services in Jordan

Regulatory Compliance Experts in Jordan

The Jordan Food and Drug Administration (JFDA) was established in 2003 by the Ministry of Health (MoH) to ensure safety, efficacy, quality and compliance of food and medicinal products according to national authority guidelines and working committees such as the Food Law and Drug and Pharmacy Law. The Drug Directorate of the JFDA is responsible for meticulous monitoring of drugs from early pre-marketing to post-marketing surveillance stages. It also oversees the Importing and Exporting, and Monitoring and Inspection departments for the approval and safe use of all medicinal products, devices, Pharmacovigilance Services, and biologics. Additionally, the JFDA includes the Clinical Studies, Information, Pricing, and Rational Drug Use departments that supervise and follow up on important aspects of drug monitoring. However, due to regular changes in legislations and regulations surrounding medicinal products the timeframe for marketing authorization can be prolonged. Therefore, it is important for manufacturers to be well-informed and constantly updated of such changes.

As a leading global contender, DDReg’s regulatory services in Jordan provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.

Our Regulatory Consulting Services In Jordan Portfolio Covers

    Country Specific Services

    Our Regulatory Affairs Consulting Services in Jordan portfolio covers:

    Regulatory Strategies

    01

    Regulatory Strategies

    The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...

    New Product Marketing Authorizations

    02

    New Product Marketing Authorizations

    Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...

    Gap Analysis and Remediation

    03

    Gap Analysis and Remediation

    In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...

    Regulatory Due Diligence

    04

    Regulatory Due Diligence

    Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...

    API & DMF services

    05

    API & DMF services

    Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...

    CMC Advisory

    06

    CMC Advisory

    DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...

    Post Approval Life Cycle Management

    07

    Post Approval Life Cycle Management

    Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...

    Certification Services

    08

    Certification Services

    Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...

    ANDA and MA Holder Services

    09

    ANDA and MA Holder Services

    Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.

    Publishing & Submission

    10

    Publishing & Submission

    Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...

    Labeling

    11

    Labeling

    With experts experienced in Consumer Health Care (CHC) products, we offer updated labeling and compliance packages that assist in the development of product labeling, artwork review & compliance, and claim substantiation.