Services
Regulatory
Our team of regulatory experts ensures your product meets all necessary international standards. We provide:
- Documentation support for local and international regulatory submissions.
- Product registration and approval processes.
- Compliance audits to keep your product aligned with evolving regulations.
- Labeling review and verification for accurate and compliant product packaging.
- Assistance with Good Manufacturing Practice (GMP) and ISO Certifications.
Product Development
From concept to market, we support every step of your product development. Our services include:
- Guidance on ingredient sourcing and formulation to meet regulatory standards.
- Product stability and compatibility testing.
- Packaging design consultation for safe and compliant packaging.
- Quality control measures throughout development.
- Technical documentation preparation and maintenance.
Acting As a Responsible Person
As your designated “Responsible Person” in compliance with regulatory requirements, we handle:
- Ensure product compliance with the relevant Regulations.
- Review product safety and efficacy before it reaches the market.
- Coordinate regulatory filings and product notifications.
- Serve as your local contact for regulatory inquiries and audits.
Training
Equip your team with knowledge and skills to ensure product safety and compliance. We offer:
- Customized training on regulatory standards and compliance practices.
- Workshops on Good Manufacturing Practices (GMP) and Quality Assurance (QA).
- Training on pharmacovigilance and risk management procedures.
- Ongoing support and updates on regulatory changes.
Reporting
We assist in monitoring and reporting for regulatory compliance, including:
- Adverse event monitoring and reporting.
- Safety evaluations and regular updates for product safety profiles.
- Risk assessment and management.
Pharmacovigilance
Our pharmacovigilance services support patient safety and regulatory compliance. We provide:
- Adverse event tracking and reporting.
- Continuous product safety assessment and risk management.
- Liaison with health authorities on safety matters.
- Support with Periodic Safety Update Reports (PSUR) and other required documentation.
Site Inspection and Qualification
Ensure your facility meets quality and safety standards with our inspection services. We offer:
- Pre-inspection readiness assessment and consultation.
- Facility inspections to identify potential compliance gaps.
- Support for qualification processes and adherence to GMP.
- Corrective Action and Preventive Action (CAPA) guidance.
See how we develop products and work with partners: Goodness Care – Jordanian developer of supplements, medical devices and cosmeceuticals.