About the Founder
Mariam Aslam, CChem, FRSC
Managing Director & Pricipal Regulatory Affairs Consultant
Mariam Aslam is a seasoned regulatory affairs professional with over 20 years of global experience across the life sciences sector. A Chartered Chemist (CChem) and Fellow of the Royal Society of Chemistry (FRSC), she brings deep expertise in Chemistry, Manufacturing and Controls (CMC), regulatory strategy, and lifecycle management.
Mariam studied and obtained a BSc (Honours) in Applied Chemistry at Manchester Metropolitan University, UK. During her studies, Mariam completed a sandwich year at
ICI Chemicals & Polymers Limited. After graduating, her career began in the laboratory as a Scientist specilaising in analytical chemistry, research and development, before transitioning into her first Regulatory Affairs profession at SSL International.
Throughout her career, Mariam has provided strategic oversight for global regulatory submissions—including INDs, CTAs, NDAs, and MAAs—for both chemical and biologic medicinal products. She has supported organisations such as AstraZeneca, Novartis, Boots Contract Manufacturing, Vifor Pharma, PAREXEL, and IQVIA. Mariam is recognised for her ability to lead cross-functional teams, formulate global regulatory strategies, and manage successful interactions with health authorities including MHRA, EMA and FDA.
Beyond her technical expertise, Mariam is deeply passionate about sharing knowledge and supporting professional growth within the regulatory field. Through InsightReg Consultancy, she offers not only high-quality regulatory affairs consultancy but also dedicated services in SOP development and training programmes designed to build capability across organisations and empower individuals at all career stages.
In alignment with her commitment to continuous professional development, Mariam will be studying part-time for an MSc in Global Medicines Development at King’s College London. This deepens her expertise in modern drug development and regulatory science, while continuing to lead InsightReg with full dedication to clients.
By combining scientific rigour with a collaborative and educational approach, Mariam helps clients confidently navigate regulatory challenges, achieve compliance, and foster internal excellence.
What We Do
InsightReg is a dedicated regulatory affairs practice providing expert support to clients across the life science sector.
We integrate strategic insight with hands-on expertise to assist organisations in addressing global regulatory complexities, from product development through post-market compliance.
Our service portfolio encompasses regulatory strategy formulation, dossier preparation, capability-building training, and customised practical support to meet your unique requirements.
Whether you are launching a new product or enhancing your internal regulatory capabilities, we deliver guidance that ensures clarity, confidence, and regulatory compliance.
InsightReg streamlines the regulatory process by offering clear, remote consultancy services.
Regulatory Affairs Consultancy
Regulatory Affairs Consultancy
Regulatory Affairs Consultancy
- Regulatory Pathway Strategy
- CTA Guidance
- MAA
- Labelling Guidance
- CMC Expertise
- Dossier Development
- Early Development Advice
- Lifecycle Maintenance
SOP Development
Regulatory Affairs Consultancy
Regulatory Affairs Consultancy
- Advice & Gap Analysis
- SOP Writing & Authoring
- SOP Editing & Proofreading
Training Programmes
Regulatory Affairs Consultancy
Training Programmes
- Training programs in Regulatory Affairs
- Bespoke training for universities
- On line virtal training for professionals seeking to enhance knowledge and skills as part of their CPD