Asclepius For Business

Company Overview

ASCLEPIUS is a Jordanian-based pharmaceutical consulting firm, founded in 2014 in Amman. We specialize in regulatory affairs (RA), training, and commercialization services for the MENA region. Our team of highly experienced professionals ensures compliance with JFDA, SFDA, GCC, and international standards

Key Achievements

WE DO IT FOR YOU WITH LOVE
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Successful product registrations (drugs, medical devices, cosmetics , Food supplements ).
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Multinational clients partnered for MENA market expansion.
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Years of uninterrupted service in pharmaceutical regulation.
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ISO-accredited training programs (ISO 13485, ISO 22716).

Our Core Values

More than just words, it's our promise in action.
The principles that define our culture and distinguish our work.

Global Excellence

    • Adherence to international regulatory standards (ICH, WHO, FDA, EU).

Strategic Partnerships

    • Collaborations with local authorities and global pharma giants.

Knowledge Sharing

    • Regular  workshops, whitepapers, and client training.

Continuous Innovation

  • Investment in AI-driven regulatory tools and eCTD solutions

Performance Integrity

Transparent processes with 100% audit readiness.

Our Services

Regulatory Affairs (RA) Services

Product Registration

  • Drugs (Rx/OTC), biologics, biosimilars.
  • Medical devices (Class I, II, III).
  • Cosmetics, nutraceuticals, and herbal products

Submission Support

  • CTD/eCTD dossier preparation.
  • Gap analysis and remediation

Post-Market Compliance

    • Renewals, variations, and label updates.

Training Programs

Regulatory Affairs Certification

    • CTD/eCTD workshops (hands-on training).
    • JFDA/GCC regulatory pathways.

Quality & Compliance

    • GMP, GLP, GDP (train-the-trainer programs).
    • ISO 13485:2016 for medical devices.

Commercial Agency

Distribution Partnerships

  • Local and MENA-wide logistics support
  • Market Entry Strategy
    • Pricing, reimbursement, and tender assistance.

Formula Development

Custom Solutions

    • Pediatric/geriatric formulations.
    • Stability testing and bioavailability studies.

Our Services​

Visit our shop to see amazing creations from our designers.

Regulatory Affairs (RA) Services​​

Product Registration

  • Drugs (Rx/OTC), biologics, biosimilars.
  • Medical devices (Class I, II, III).
  • Cosmetics, nutraceuticals, and herbal products.
Read More

• Submission Support

    • CTD/eCTD dossier preparation.
    • Gap analysis and remediation.
Read More

Post-Market Compliance

    • Renewals, variations, and label updates.
Read More

Training Programs

Regulatory Affairs Certification

    • CTD/eCTD workshops (hands-on training).
    • JFDA/GCC regulatory pathways.
Read More

Quality & Compliance

      • GMP, GLP, GDP (train-the-trainer programs).
      • ISO 13485:2016 for medical devices.
Read More

Commercial Agency

Distribution Partnerships

      • Local and MENA-wide logistics support
Read More

Market Entry Strategy

        • Pricing, reimbursement, and tender assistance
Read More

Formula Development

Custom Solutions

        • Pediatric/geriatric formulations.
        • Stability testing and bioavailability studies.
Read More

Clients & Partners

Pharmaceutical Manufacturers

[Examples: ABC Pharma, XYZ Life Sciences]

Hospitals & Clinics

[Example: Jordan Royal Medical Center]

Government Agencies

JFDA, SFDA, GCC regulatory bodies

Client Success Stories

Accelerating Medical Device Approval

Discover how we've helped industry leaders overcome regulatory challenges and accelerate their market entry

 

“ASCLEPIUS reduced our Class III device registration timeline in  Jordan from 12 months to 6 months through strategic JFDA engagement.”
Reduced our cosmetics product’s registration timeline in Jordan from 10 months to 3 months through strategic JFDA engagement.”

12 Months

 (Standard Timeline)

6 Months

 (With ASCLEPIUS)

50%

Time Reduction