About

Aurora CMC Consulting Oy

Aurora CMC Consulting, established in 2021 provides Regulatory Chemistry, Manufacturing, and Control (“CMC”) consulting services to the pharmaceutical / biopharmaceutical industry. This includes CMC, regulatory, and strategic consulting services. Aurora CMC provides timely, reliable, high quality CMC program support for your program needs.

Based in the Central European Time zone, Aurora CMC Consulting provides remote CMC expertise nimbly to EU and US time zones with familiarity of ways of working in different corners of the world. The Company is looking for opportunities to contribute to delivery of therapies to meet unmet medical needs through partnerships.

The CEO/Owner/Principal Consultant, Mia Kiistala

Transcribing CMC development to packages that meet today’s risk based regulatory expectations:

Over 19 years of experience in driving CMC priorities for pharmaceutical and biopharmaceutical programs in industry setting.
Appreciation for comprehensive CMC development through direct experience in supporting and driving CMC priorities in Product Development, Quality and Regulatory organizations.
Hands on experience in driving CMC priorities for therapies derived from biopharmaceutical and synthetic processes including cytokines, mAbs, fusion proteins, pegylated protein and antisense oligonucleotides.
Hands on experience in driving Regulatory CMC priorities for sterile injectable DP.
Experience in developing Regulatory CMC strategy for accelerated programs, innovative technologies and platform concepts.
Experience in assessing regional considerations.

Read more on my LinkedIn profile Mia Kiistala.

Year 2020 made all of us pause and impacted people’s lives in different ways. For me year 2020 turned into a calling to return to my roots in Rovaniemi, Finland. Thankfully during 2020, we also came to realize the possibilities of remote work. Therefore, although there are no pharmaceutical/biopharmaceutical companies located at the Arctic Circle, Finland, I plan to continue to contribute to delivering therapies to patients, now remotely, with Aurora CMC Consulting Oy.

Aurora CMC Consulting contributes to the delivery of therapies to meet unmet medical need through partnerships with drug developers and manufacturers.

Mia Kiistala

Mission

Help medicinal products reach patients by providing knowledge.

Vision

Create value to development and licensing of medicinal products though partnerships.