Inhaler: Regulatory, quality,
device & clinical requirements

Consultant for Medical Device Development and Regulatory Affairs After finishing his PhD and postdoctoral research in Immunology Dr Goßlar started in 2000 his industry career in the biotech business where he held various positions including drug regulatory affairs. In 2008 he joined Sandoz GmbH. Prior to joining Granzer, Uwe Goßlar was globally responsible for all medical device aspects of Novartis/Sandoz‘ biosimilar projects. He was personally involved in successful development and certification/licensing of pen- and autoinjectors (e.g. CE marking/510(k)/MDL/ISO13485 and MDSAP certification) as well as marketing authorisation procedures for drug-device combination products including pre-filled pens and syringes in a variety of different markets globally (e.g. Centralized Procedure/NDA/BLA). Dr Goßlar joined Granzer Regulatory Consulting & Services in July 2019 as consultant for medical device development and regulatory affairs.
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Carina Simons is a pharmacist and completed her M.D.R.A. in Bonn in 2019. Since 2016, she has been working in drug regulatory affairs in the evaluation of drug quality with a focus on inhaled products. She has been a member of the INH Working Party (Inhalations) of the EDQM since 2023.

Senior Consultant CMC Dr Zaman qualified as a Pharmacist after initially gaining a BPharm (Hons) degree and later a PhD in Drug Delivery - both from King's College London. He has over 20 years' experience, where 10 years were spent working for the MHRA (UK) as a Senior Pharmaceutical Reviewer/Assessor. He has also worked with several companies including PAREXEL Consulting, GSK and GENPACT. Mustafa joined Granzer Regulatory Consulting & Services as a Senior Consultant in November 2022. Mustafa has experience in leading strategic, technical and / or process issues for a wide range of therapeutic/product types, including new chemical entities, generic products, combination products, drug-device combinations and clinical trials applications. He is experienced in European and US procedures including regulatory authority meetings, Clinical Trial Applications and Market Authorisations. Mustafa is a member of the MHRA Analytical Quality-by-Design (AQbD) Working Party, a Member Centre of Pharmaceutical Medicine Research (CPMR) Scientific Advisory Board at King's College London and holds four academic (Honorary) posts at three UK Universities.
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Project Director Medical Development Roman has an academic education in molecular biology and substantial experience in the scientific, medical, and pharmaceutical industries since 2001 based on research activity in the field of development of molecular diagnostic techniques for thyroid cancer and based on his experience in regulatory affairs and quality management, including MP/MD/IVD registration activities and (regulated) clinical development.
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