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Regulatory Services

We provide pharmaceutical companies and drugstores with CTD (Common Technical Dossier) Filing, review of regulatory files for registration or re-registration following CTD requirements, e-submission (eCTD) support, response to regulatory authorities for deficiency letters, and stability study review and justification.

Product Development Services

We can help develop new products, including pharmaceuticals, medical devices, supplements, cosmetics, and personal care products. We also help to resolve troubleshooting during the product development stage or per post-approval changes regulations.

Acting As a Responsible Person Services

For companies outside Jordan who want to introduce products in Jordan, we can offer an independent representation with JFDA and act as a “responsible person.” This includes the following services:

  • Act as an Authorized Representative for the company with the Jordan Food and Drug Administration.
  • Become a Registered Address for the JFDA.
  • Provide reviews and ensure the registration of the products before the JFDA application.
  • Keep and Update the Technical documentation.
  • Provide detailed Technical Documentation Review.
  • Advise on Labeling Compliance and Language Requirements.
  • Incident Reporting and Complaint Handling.
  • Support on Conformity Assessment & Certification Procedures.
  • Support on Safety Post-Marketing Surveillance.
  • Jordan Trademark Submissions.
  • Follow up on all required analytical activities in Jordan.

Training Services

We offer several in-house and online training workshops related to the pharmaceutical industry. Here are a few of our workshops:

  • Quality Metrics in the Pharmaceutical Industry.
  • Technical Aspects of the Pharmaceutical Industry and Regulatory Affairs.
  • Cleaning Validation for Cosmetics and Medical Device Manufacturers.
  • Introduction to ISO 17025 Training.
  • Method of Analysis Development Training.
  • Analytical Methods Validation Training.

Reporting Services

  • Pharmaceutical expert reports, clinical and non-clinical.
  • Pharmacokinetics and bio-waiver reports.
  • Cosmetic product safety reports.

Pharmacovigilance Services

  • Pharmacovigilance System Setup: Set up a comprehensive system that complies with the requirements of the relevant regulatory authorities. The system will include approved procedures for adverse drug reaction reports, PSUR development, a qualified person for pharmacovigilance (job description), training, and reporting. In addition, staff training on implementing and maintaining the pharmacovigilance system.
  • PSUR Reporting: Preparation of PSURs that review scientific literature, evaluate the company’s data individually, and prepare complete and ready-to-submit PSURs for human medicinal products. The PSUR reporting service includes:
    • A thorough review of scientific literature in medical sources
    • Assessment, evaluation, and processing of suspected adverse drug effects (ADRs)
    • Analysis of company-specific data
    • Preparation of a customized periodic safety update report (PSUR).

Sites Inspection and Qualification Services

  • We provide auditing and certification services to help manufacturers of healthcare products comply with the safety and quality regulations as follows:
    • Gap analysis for pharmaceuticals or Cosmetics sites versus GMP requirements, including Quality Management systems (QMS), SOPs, and implementation.
    • Gap analysis for analytical labs versus ISO 17025 requirements, including quality system and SOPs.
    • Pre-inspection audits for sites or labs expecting regulatory inspection.
    • We can help upgrade cosmetic manufacturing facilities for registration at the Ministry of Health for manufacturing General Sales List Products (GSL).
    • We also help upgrade manufacturing facilities to comply with ISO 13485.
    • Support in Site Master File (SMF) preparation.
    • Support in specific Standard Operation Procedures (SOPs) preparation.

Start Your Project Today

Contact us below, and we will get in touch and kick off the discussions on how to work together.