Product Classification and Regulatory Assessment
- Determining whether a product is cosmetic, cosmeceutical, or borderline item based on definitions in each jurisdiction.
- Recommending the applicable framework.
Cosmetic Dossier Preparation and Registration
- Assembling required documentation—product composition, safety assessments, manufacturing data—under country regulations or equivalent dossiers.
- Submitting product details to regional portals (e.g. SFDA Ghad System).
- official communications with authorities, addressing queries or additional data requests, and tracking dossier status.
Labeling Compliance
Ensuring alignment with mandatory labeling requirements: country-specific language rules, and precautionary statements.
Translation and Localization
- Translating technical files, labels, and safety assessments into required languages, ensuring precise medical or scientific terminology.
- Tailoring content to reflect local consumer preferences and specific regulatory conventions.
- Reviewing translations for accuracy, consistency, and compliance with local guidelines.
Regulatory Agency Liaison
- Act as the primary point of contact with health authorities.
- Track submission timelines, manage queries or deficiencies, and ensure timely updates or modifications in compliance with changing regulations.
- Draft responses to agency queries and deficiency letters to expedite approvals.
Technical and IT Support
Implementing or managing electronic portals for swift product notifications or updates.
Monitoring Regulatory Changes
- Keeping track of evolving cosmetic regulations, restricted ingredient lists, labeling updates, and compliance deadlines in target markets.
- Providing proactive guidance to adapt product formulations or claims as new rules emerge.
Post-Market Surveillance and Cosmetovigilance
- Kernel Healthcare is mandated to align its Cosmetovigilance activities with the Jordan Food and Drug Administration (JFDA) guidelines, ensuring the comprehensive collection, evaluation, and reporting of adverse events linked to cosmetic products. By integrating local requirements with global benchmarks, Kernel Healthcare fosters a transparent, consumer-centric framework designed to uphold public health, reinforce regulatory compliance, and contribute to the overall integrity of Jordan’s cosmetics market.