Anna Holmberg, PhD
CEO
- anna(a)emmace.se
- +46 (0)733 73 07 53
Dr. Holmberg holds a PhD degree in Physical Chemistry and has over 20 years’ experience of pharmaceutical and medical device development. She has previously been CEO of two companies, a CRO offering development of topical pharmaceutical and medical device products, and a start-up company developing its own medical device products. In addition, she is well acquainted with CMC regulatory affairs and the regulatory framework of medical devices. She has been a self-employed consultant in Pharmaceutical and Medical Device development with focus on regulatory affairs, product development, technical documentation, clinical and biological evaluations, and management of the CMC development process. She has experience from all classes of medical devices (class I, IIa, IIb and III).
Mårten Svensson, PhD
Business Development Manager
- marten(a)emmace.se
- +46 (0)709 59 45 53
Dr. Mårten Svensson has over 20 years of experience in the pharmaceutical industry and industry consortiums. His primary focus has been characterisation of inhalers, nebulizers, and nasal products. After 13 years at big pharma, where he developed in vivo-in vitro correlation methods for inhaled drugs, he founded Emmace Consulting in 2011. Under his leadership, Emmace has become a CRO-lab recognized for its innovative rAPSD methodologies and has contributed to today’s regulatory landscape this bioequivalence route.
Peter Elfman
Laboratory Manager
Mr. Elfman is a MSc in Chemical Engineering with more than 20 years of experience of R&D work with aerosols and medical devices within AstraZeneca. As a Senior Scientist in the Analytical Science department at AstraZeneca, he was involved in medical device development (inhalers), aerosol characterization, formulation development, stability studies, validation and development of test methods and equipment, laboratory automation (e.g. development of equipment for inhaler testing), software development and risk assessments. He is very experienced in GMP coordination work and regulatory documentation (especially Module 3 documents for NDA, JNDA and MAA) and in writing answers to questions from regulatory authorities in EU, Japan and the USA (FDA). In recent years Mr. Elfman has taken several university classes within the quality area and has also worked in the packaging industry (Tetra Pak) for three years.
Elisabet Rappe
Manager, Medical Device Testing
Mrs. Rappe has worked with biocompatibility compliance according to ISO 10993 including ISO 18562 (Biocompatibility evaluation of breathing gas pathways in healthcare applications), for many years in the medical device manufacturing sector. She has also worked hands-on regarding upgrade of biocompatibility documentation files to comply to MDR. Currently, her main responsible is the accreditation for ISO 17025 and sample analysis of the ISO 18562 tests at Emmace.
Kyrre Thalberg, PhD
Senior Adviser – Inhalation Product Development | Adjunct Professor – Department of Food Technology, Engineering and Nutrition, Lund University
For almost 30 years, Dr. Thalberg has worked in the field of dry powders for inhalation with AstraZeneca. He has been working with most kinds of dry powder formulation systems and have provided key contributions to a range of successful AZ inhalation products, for instance the Turbuhaler product family.
The toolbox of skills around dry powder inhalers contains selection of raw materials, their compositions and manufacturing processes, and well as physical characterization of formulations (material science), which includes different types of particle size analysis, bulk density and flowability assessment.
Read full CV here
Lars-Magnus Bjursten, MD, PhD
Senior Adviser – Biocompatibility Evaluation of Medical Devices
Dr. Bjursten is senior professor at Lund University, Bioimplant research and affiliated professor at UCSD (University of California San Diego, Dept. for Bioengineering). He is board certified specialist in internal medicine as well as clinical immunology and transfusion medicine. He has been working in the international ISO TC 194 committee that is developing the ISO 10993 series of standards for more than 25 years and is chairman of the Swedish mirror committee for 20 years. He is since 2021 convener for ISO TC121/SC3/WG13 that is responsible for the ISO 18562 series: Biocompatibility evaluation of breathing gas pathways in healthcare applications. He has been leading the revision leading to the current version of the standard. He has been consultant to industry in biological safety evaluation and risk management of medical devices for 20 years and has been in the SCENIHR (Scientific Committee on Emerging and Newly Identified Risks in EU) working group on Guidance on the Determination of Potential Health Effects of Nano materials Used in Medical Devices.
Read full CV here
Bo Olsson, PhD
Senior Adviser – Inhalation Science
Dr. Olsson has more than 30 years of experience of inhaled formulations having spent about equal time on CMC and clinical pharmacology at his former employer, AstraZeneca. In 2015 he took a position as senior inhalation consultant at Emmace Consulting AB. His specialty is IVIVC with particular emphasis on predicting in vivo outcomes, such as lung disposition, from in vitro data, and is a well-known author and speaker on this topic.
Read full CV here
Jonas Jakobsson, PhD
Senior adviser – Aerosol Science and Technology
Ann Ohlsson
Senior Analytical Scientist
Ms. Ohlsson has a MSc in Chemical engineering with a degree from Lund University. She has worked in the pharmaceutical industry for more than 25 years as a senior analytical scientist. She has provided analytical support to projects in different stages of development ranging from early stages of development to products approved for market. She has an extensive experience in several areas covering e.g.,
– LC method development and validation
– dissolution testing
– analytical support to formulation and device development
– support to non-clinical studies (Principal Investigator)
– planning and performing stability studies both for development work and according to ICH guidelines
– writing regulatory documents for CTA and NDA
Jamshaid Ashiq
Senior Analytical Scientist
Mr. Ashiq holds a master’s degree in environmental chemistry from Umeå University Sweden following a postgraduate degree from Linköping University Sweden, which have equipped him with significant expertise in analytical chemistry and method development for environmental analysis. Following his studies, Mr. Ashiq worked for more than two years at Eurofins Pegasus lab Sweden, focusing on the analysis of volatile organic compounds (VOCs) in air and various materials, as well as working with PCBs and polycyclic aromatic hydrocarbons (PAHs). Currently Mr. Ashiq is working as a Senior Analytical Scientist at Emmace where he leverage his extensive background in analytical chemistry to drive method development and perform precise analysis. At Emmace, his main focus is testing of medical devices according to the ISO 17025 and ISO 18562 standards.
Jackie Stuckel
Senior Inhalation Analyst
Mrs. Stuckel is an expert in delivered dose, impactor testing, and testing using laser instruments.
Tove Sörnmo
Senior Inhalation Analyst
Mrs. Sörnmo has a MSc in Biotechnical engineering from Lund University. She has worked in the pharmaceutical industry as an analytical scientist since 2017 and has experience in GMP at QC laboratory and as analytical support in the inhalation industry. At Emmace, her main focus is testing of medical devices according to the ISO 17025 and ISO 18562 standards.
Camilla Drott
QA Manager
Lisa Theorin, PhD
Senior Device Analyst
Kristina Busch
Lab administration
- kristina(a)emmace.se
- +46(0)731 58 76 79
Ms. Busch has a long background as administrator in different companies. Ms. Busch helps with everything from orders, postal service and lab assistance.