Regulatory Affairs Services 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 JFDA is responsible for meticulous monitoring of drugs from early premarketing to postmarketing 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 wellinformed and constantly updated of such changes.
Why Choose DDReg for Regulatory Affairs Consulting in Jordan?
DDReg’s regulatory affairs services in Jordan provide ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent Jordan Regulatory Consultant updates 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 covering Pharmaceutical Regulatory Affairs Jordan and medical device regulations support.
Our Regulatory Consulting Services In Jordan Portfolio Covers
- Specialized Regulatory Affairs Consulting for JFDA
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- Regulatory Labeling
- eCTD Regulatory Submission and publishing
Our Regulatory Affairs Consulting Services in Jordan portfolio covers:
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
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...
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...
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...
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...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
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...
