Bio-Impact provides end-to-end regulatory, scientific, and market access support across pharmaceuticals, biologics, medical devices, and other health-related products. Our integrated approach ensures full alignment between regulatory strategy and commercial objectives, enabling efficient approvals and successful market entry across Egypt and the Gulf.
Industries We Support
Specialized regulatory and market access expertise across the life sciences spectrum.
Pharmaceuticals
Branded, generic, and specialty drug products
Biologics
Biosimilars, vaccines, and advanced therapies
Medical Devices
Class I–III devices and IVDs
Other Health Products
Cosmetics, supplements, and herbal medicines
What We Deliver by Product Type
Tailored regulatory and market access services aligned with the requirements of each product category.
Full lifecycle support for small molecules and biologics, including biosimilars — from early development through dossier preparation, submission, and post-approval lifecycle management.
CTD Module Preparation
Full compilation of Modules 1 through 5 with scientific review
eCTD Compilation & Validation
Submission-ready electronic dossiers and lifecycle maintenance
Gap Analysis & Optimization
Dossier review to ensure completeness and compliance
CMC Advisory
Chemistry, manufacturing, and controls strategic guidance
Clinical & BE Strategy
Bioequivalence and clinical development planning
Biologics & Biosimilars
Specialized expertise for biological products and biosimilar pathways
Pricing & Reimbursement
Market access submissions and payer strategy
Lifecycle Management
Variations, renewals, and post-approval activities
Comprehensive regulatory support for medical devices — from classification and pathway identification through registration, audits, and post-market compliance.
Classification & Pathway
Device classification and regulatory pathway identification
Technical Documentation
Complete technical file preparation and review
Clinical Evaluation Reports
CER preparation aligned with applicable standards
Notified Body Coordination
Liaison and submission support throughout the review process
Labeling & IFU Compliance
Labels and instructions for use aligned with applicable standards
Post-Market Surveillance
Vigilance systems, monitoring, and ongoing compliance
Regulatory support for cosmetics, food supplements, herbal medicines, and other health-related products — covering classification, compliance, and market entry.
Product Classification
Determining the correct regulatory category and pathway
Compliance Review
Assessment against applicable regional regulations and standards
Dossier Preparation
Complete documentation aligned with authority requirements
Labeling Adaptation
Localization and compliance with regional labeling rules
Market Entry Strategy
Roadmap for successful registration and commercial launch
Our Methodology
A structured, transparent process from initial assessment to successful market entry — applied consistently across all product types.
Assessment
Gap analysis and regulatory pathway evaluation
Strategy
Tailored roadmap aligned with commercial goals
Submission
Dossier preparation and authority engagement
Approval
Query response and approval facilitation
Lifecycle
Post-market support and ongoing compliance
Markets We Cover
Direct engagement with regulatory authorities across Egypt and the Gulf Cooperation Council.
Egypt
EDA
Saudi Arabia
SFDA
UAE
MOHAP / DOH
Kuwait
KDFC
Qatar
MOPH
Bahrain
NHRA
Oman
MOH
Visit Epidis Pharma
For deeper local expertise and direct engagement with the Egyptian Drug Authority (EDA), explore our sister company Epidis Pharma — a dedicated partner specialized in the Egyptian market.
Planning Your Market Entry?
Let's discuss how Bio-Impact can accelerate your regulatory pathway and unlock new markets across Egypt and the Gulf.
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