Regulatory Compliance Solutions
Medical Device-EU MDR 2017/745
Providing comprehensive regulatory guidance for medical device submissions, ensuring compliance with EU MDR 2017/745 and FDA regulations to facilitate market access and product safety.
MENA Submission Support
Offering tailored support for pharmaceutical, medical, and biological product submissions in the MENA region, including new applications and life cycle management, aimed at streamlining the approval journey and increasing the likelihood of successful market entry.
Biosimilar review and submission
Provide support in preparing and submitting biosimilar dossiers, including analytical and clinical comparability assessment, in alignment with EMA and regional regulatory requirements.
Quality Management Systems
Expertise in ISO 13485 implementation, helping clients establish effective quality management systems that meet international standards, ensuring product quality and regulatory compliance throughout the product lifecycle.
BUSINESS development Solutions
Regulatory Market Entry Strategy
Customized go-to-market plans for MENA, EU, and U.S. regions with regulatory alignment.
Partner & Distributor Identification
Supporting clients in finding the right local partners across the MENA region and beyond.
Regulatory Intelligence & Competitor Analysis
Insights on evolving regulations and competitive landscapes to guide decision-making.
Dossier Gap Assessment for Licensing Opportunities
Evaluating product readiness for in-licensing and out-licensing based on regulatory compliance.
training COURSE
Specialized training programs in medical device regulations, ISO 13485, FDA submissions, EU MDR, and MENA regulatory frameworks.
Our courses are designed to empower regulatory teams, quality professionals, and industry stakeholders with practical, up-to-date knowledge tailored to real-world challenges.