Mån 4 dec / År 41 / Nr 5 2023

The Science and Compliance of Pharmaceutical Development

Scius Pharma Support AB is a privately owned independent consulting firm, supporting pharmaceutical product development initiatives of life science companies of all sizes.

The core competences of Scius Pharma Support AB revolve around the activities that in the end will support the Chemistry, Manufacturing and Controls (CMC) section of the regulatory package for a new medicinal product.

The company was founded in 2013 by Fredrik Nicklasson, a pharmacist with a PhD in Pharmaceutics and extensive experience of product development within the pharma industry. Scius is currently a one-person operation with Fredrik as the owner as well as the operative consultant.

In early 2016, the company moved to Medicon Village in Lund in order to be closer to the many small size virtual and start-up companies thriving in ’the Village’.

“What Scius aims for is ‘Science’ and ‘Compliance’. Those two words sums it up,” says Fredrik Nicklasson. “Whether your immediate objective is proof of concept or an application for registration approval,” he continues, “you need to prove the technical viability of your project. The Compliance part deals with finding out what you need to prove, whether it’s to a potential financial backer or to a regulatory authority. The Science part is all about how to prove it.”

Can Quickly On-Board Projects
Assignments can be as diverse as preclinical formulation work and tech transfer for commercial production. “Being a small firm with no in-house laboratory or manufacturing capabilities, the ability to collaborate and coordinate is key,” Fredrik observes. “And with being small comes great flexibility and the ability to quickly on-board projects.”

Often, client companies need assistance with scientific writing or review of regulatory submission packages. “Again, Science and Compliance,” says Fredrik. “The content must be scientifically sound and needs to cover the regulatory requirements. And if you can present a concise and coherent narrative, a lot of misunderstanding can be avoided.”

And the company name? Scius is latin, meaning knowledgeable person or someone with expertise. “The name is more of an aspiration than a statement of fact,” Fredrik concludes, “in this line of business you need to always be up-to-date if you want to stay relevant.”