Our services are aligned with international regulatory standards
Supporting regulatory compliance in line with the requirements of the following health authorities and organizations:
Pharma Elite provides regulatory consulting, CTD dossier preparation, PDE studies, GMP compliance, Training and audit readiness services for pharmaceutical manufacturers across MENA and Saudi Arabia.
Pharma Elite provides end-to-end regulatory and quality support for pharmaceutical manufacturers in Egypt and Saudi Arabia, covering regulatory strategy, CTD preparation, authority interactions, GMP compliance, deficiency response handling, training, and lifecycle management in accordance with EDA and SFDA regulations.
Pharma Elite is a pharmaceutical regulatory and quality consulting firm supporting pharmaceutical manufacturers with regulatory affairs, CTD dossier preparation, GMP compliance, and authority interactions across Egypt and Saudi Arabia.
Our mission is to support pharmaceutical companies in achieving regulatory and GMP compliance through practical, authority-ready solutions.
Our vision is to be a trusted regulatory partner delivering clear, compliant, and sustainable outcomes.
We support pharmaceutical companies across Egypt, Saudi Arabia, and selected regional markets, providing regulatory and quality consulting aligned with international standards.
Discover the unique advantages that set us apart as your trusted regulatory partner
A specialized team with hands-on experience in regulatory affairs, CTD preparation, GMP compliance, and authority interactions with EDA and SFDA.
Regulatory and quality solutions tailored to each product and manufacturing setup, based on applicable regulatory pathways and authority requirements.
Services aligned with international regulatory guidelines, including EDA, SFDA, EMA, and ICH requirements.
End-to-end regulatory and quality support covering strategy, dossier preparation, authority submissions, deficiency handling, and post-approval compliance.
A reliable regulatory and quality partner supporting pharmaceutical companies throughout inspections, submissions, and ongoing compliance activities.
Supporting regulatory compliance in line with the requirements of the following health authorities and organizations:
End-to-end services designed to streamline your regulatory pathway and ensure compliance at every stage.
Regulatory strategy development and authority-facing consultation to support pharmaceutical product registration, variation management, and regulatory decision-making in line with EDA and SFDA requirements.
Targeted GMP and regulatory training programs aligned with EDA and SFDA requirements to support inspection readiness, compliance awareness, and effective implementation of regulatory expectations within pharmaceutical organizations.
GMP gap analysis, compliance audits, and quality system reviews to identify regulatory gaps, assess compliance risks, and prepare manufacturing sites for regulatory inspections and authority audits.
Toxicological and quality risk assessments including impurity evaluation, PDE/OEL calculations, exposure-based safety justification, and cleaning validation support in accordance with ICH and international guidelines.
Preparation and review of CTD and technical dossiers for regulatory submission, including Module 2 summaries and Module 3 quality documentation, ensuring authority-ready and compliant submissions.
End-to-end regulatory support for the Saudi market, including regulatory submissions and post-submission activities in compliance with SFDA requirements.
Comprehensive regulatory support for accessing the Saudi Arabian market through SFDA compliance.
Account creation and regulatory setup with SFDA platforms
Regulatory support for product registration in Saudi Arabia
SFDA advertising and marketing compliance
Certificates required for local and international distribution
Customs clearance and ongoing regulatory follow-up
A structured regulatory and quality process designed to support authority submissions, inspections, and ongoing compliance.
We review your product, manufacturing setup, and existing documentation to identify regulatory requirements, compliance gaps, and the appropriate regulatory pathway.
We define a clear regulatory and quality strategy covering CTD requirements, submission pathways, timelines, and authority expectations in line with EDA and SFDA regulations.
We prepare and review CTD and technical dossiers, including Module 2 summaries, Module 3 quality documentation, and supporting risk assessments such as PDE/OEL and impurity evaluations.
We conduct GMP gap analyses, compliance audits, and mock inspections, and support CAPA development to ensure readiness for regulatory authority inspections.
We provide post-submission and post-approval support, including deficiency handling, variations, renewals, and ongoing regulatory and quality compliance management.
Our services are delivered by a multidisciplinary team of senior regulatory and quality professionals with extensive experience across pharmaceutical manufacturing and regulatory authorities.
Our team includes former regulatory professionals with hands-on experience in national and regional health authorities, contributing to regulatory assessment, inspection readiness, and authority-facing decision-making.
Team members have supported and participated in GMP inspections, audits, and regulatory assessments across pharmaceutical manufacturing sites in Egypt and international markets, covering sterile and non-sterile facilities.
Our experts have contributed to the successful registration, variation management, and lifecycle support of dozens of pharmaceutical products across multiple dosage forms and regulatory pathways.
District 39, Obour City, Qalyubia Governorate 6361276
Regulatory and compliance hub for Egypt operations
We have proudly delivered our regulatory and compliance services to leading pharmaceutical companies, health authorities, and research organizations worldwide
Our experts have worked on regulatory, quality, and compliance projects involving multinational pharmaceutical organizations across different therapeutic areas and dosage forms.
We have supported local and regional pharmaceutical manufacturers through registration activities, GMP readiness, and compliance improvement initiatives.
Team experience includes authority-facing activities such as dossier assessments, inspection readiness, deficiency responses, and regulatory follow-up activities.
Get expert guidance tailored to your company's regulatory needs and objectives.
