Life Science Adviser
& CMC Expert
I offer expert services to Life Science companies focusing on development of medical devices and pharmaceuticals.
Services include planning and management of development projects.
Services also include performing project activities such as
– product development for clinical trials / clinical investigations
– outsourcing of manufacturing
– tech transfer to CMO and CRO
– CMC support and coordination including formulation development, analytical development, and stability studies
– CMC documentation for clinical trials (IMPD/IND) and handling of CMC questions from authorities
– technical documentation for medical devices
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"I have had the pleasure of working with Anna in a project critical to our company's progress. Anna's extensive experience has been pivotal for Oxy Solutions. Her responsibilities were related to project development and CMC (formulation and process development). Anna also headed a choice of, and technical transfer to CDMO.
Anna’s high scientific competence combined with her excellent ability to drive tasks and activities has been invaluable to us. Anna always delivers as agreed, and proactively ensures that tasks are addressed, followed up and executed according to agreed plans. She is clear in her communication and recommendations, and she has been critical to ensure our project progress. I highly recommend Anna."
Marianne Mæhlum
CEO Oxy Solutions 2019-2021
"I worked with Anna at Zelmic Technologies AB while she was a project manager and when she later became the CEO of the company.
Throughout these three years, the contact with Anna was always a very positive experience - both over a cup of coffe and in any type of formal meeting. As a project manager she keept all activities on track - always with a smile on her face ! - and held the contact to several customers in an excellent way. She also made everyone in the team feel the importance of their contributions and our progress."
Johan Borgström
Senior Researcher, Saint-Gobain Ecophon AB
"Anna Holmberg, myself and two other persons were a small and dedicated team, who worked together very tightly during nearly two years, from November 2018 to October 2020 at Pharmiva AB. Anna was CEO and I was responsible for the production. Under Anna’s guidance, with quite small means and a tight time plan, we got a CE mark according to MDD of Vernivia Vaginal Mousse, and ISO 13485 certification of the organisation. We took Pharmiva from a design and development phase to scaling up of the technology, identified suppliers and manufactured the first commercial batches, and also delivered post market surveillance clinical trial materials to further strengthen the product. Anna was a fantastic colleague and CEO. She has a deep knowledge in science and regulatory matters and is strategic in her work. Anna is also an excellent project leader; she can set up tough timelines which we were always able to hold – thanks to the structured work processes and the tight teamwork and collaboration she managed. Anna has a great respect and trust in her colleagues, she easily delegates actions, and I think this is one reason for why I really enjoyed working with Anna, and that we in a short time could achieve so much."
Susanna Liljedahl
Project Manager, Zelmic AB
"I had the pleasure to work with Anna during her two years at AstraZeneca, we worked close together in several projects in the compilation of the Quality part of clinical trial applications and responses to authority questions.
I appreciate Anna´s way of listen to other project team members experience and knowledge, her ability to take efficient risk based decisions and her dedicated and organised way of working to keep timelines.
I therefore recommend Anna to positions for example in the Regulatory CMC area."
Helen Dahlberg
Senior CMC Documentation Coordinator,
AstraZeneca R&D Lund, 2000-2011
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