Pharmaceuticals
Bringing a medical product to market is challenging.
We use our specialized expertise to ensure full compliance
Product Classification and Development Pathway
Determine whether the product is classified as a novel drug, generic, biosimilar, or over-the-counter (OTC).
Identify the specific authority responsible for pharmaceutical registration in the target country (e.g. the Saudi Food and Drug Authority [SFDA], Jordan Food and Drug Administration [JFDA], Egyptian Drug Authority [EDA]).
CTD/eCTD dossier preparation
Common Technical Document (CTD) Assembly:
- Structuring the CTD modules
(Module 1: Administrative; Module 2: Summaries;
Module 3: Quality; Module 4: Nonclinical;
Module 5: Clinical) in compliance with country guidelines.
- Ensuring complete and coherent documentation of quality, efficacy, and safety data.
Electronic Submissions (eCTD)
- Formatting and validating submissions via the Electronic Common Technical Document system.
- Managing rolling submissions for accelerated approvals, if applicable .
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.
Regulatory Agency Liaison
Labeling Compliance
Ensuring that product labels and package inserts conform to regional regulations regarding indications, usage instructions, contraindications, and adverse event warnings.
Translation and Localization
Translating dossiers, labeling, and promotional materials into required languages with precision, maintaining terminology specific to medical and regulatory contexts.
Adjusting content to align with local legal requirements, cultural norms, and healthcare system nuances.
Ongoing Regulatory Monitoring
Tracking updates to agencies’ guidance and regulations.
Pharmacovigilance and Post-Marketing Surveillance
At Kernel, we prioritize patient
well-being by aligning every stage of our pharmacovigilance activities with
Jordan Food and Drug Administration (JFDA) guidelines. Through systematic
processes for Individual Case Safety Report (ICSR) handling, signal detection,
and ongoing risk assessment, we proactively manage product safety profiles and
comply with both national regulations and global best practices. By conducting
periodic safety updates, implementing targeted risk minimization measures, and
fostering transparent communication across the healthcare ecosystem, Kernel
Healthcare creates a patient-centric environment rooted in quality, integrity,
and regulatory excellence.