Ayesha Saleem — Post-market Consultant (Ophthalmic/Other)
Regulatory, Pharmacovigilance, and Quality Specialist
A highly accomplished and adaptable Regulatory, Pharmacovigilance, and Quality Specialist with robust expertise in the pharmaceutical and medical device industries. Ayesha possesses extensive knowledge in CTD/eCTD documentation, ensuring seamless compliance with EU, UK, and FDA regulations. Her capabilities span literature monitoring, QMS development and management, and comprehensive lifecycle man...
Experience: 3+ years
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
Ayesha Saleem provides regulatory consulting services to clients in:
Credentials & Recognition
Education & Credentials
Holds a Doctor of Pharmacy and an MSc in Regulation and Evaluation of Medicines and Health Products from esteemed institutions, including the University of Lisbon. This robust academic foundation provides a deep understanding of pharmaceutical sciences and regulatory frameworks, directly enhancing expertise in medicinal product and health product evaluation. Their education is highly valuable for medtech companies seeking professionals with a strong scientific and regulatory acumen.
Invited speaker at national conferences, presenting expert perspectives on the regulatory framework of medicinal cannabis across Europe. This recognition highlights their status as a thought leader and their ability to disseminate complex regulatory information effectively within the industry.
Professional Experience
A seasoned Regulatory, Pharmacovigilance, and Quality Specialist with extensive experience across various roles, including Regulatory Affairs Associate and Consultant. Proven ability to manage CTD/eCTD documentation, ensure EU, UK, and FDA compliance, and oversee QMS participation and lifecycle management for diverse product categories. Demonstrated success in preparing regulatory dossiers, leading audits, and implementing CAPA investigations for clients. Their career progression showcases a deep commitment to regulatory excellence and comprehensive product lifecycle support.
Executive Summary
Professional Overview
A highly accomplished and adaptable Regulatory, Pharmacovigilance, and Quality Specialist with robust expertise in the pharmaceutical and medical device industries. Ayesha possesses extensive knowledge in CTD/eCTD documentation, ensuring seamless compliance with EU, UK, and FDA regulations. Her capa...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Regions: EU, US
- Background: 3+ years of regulatory experience.
Cruxi view
With 3 years of dedicated experience, Ayesha Saleem offers a robust blend of regulatory, pharmacovigilance, and quality expertise, directly benefiting medtech companies navigating complex global compliance. Her deep understanding of CTD/eCTD documentation and proven ability to ensure seamless compliance with EU, UK, and FDA regulations, coupled with proficiency in ISO 13485 and EU MDR, makes her an invaluable asset for medical device manufacturers. Ayesha's capabilities extend to QMS development and management, crucial for establishing and maintaining a compliant operational framework. Her experience in preparing regulatory dossiers and adeptly navigating intricate frameworks like EMA, MHRA, and FDA positions her as a strategic partner for achieving market access and sustaining product lifecycle.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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