Regulatory knowledge can expand a market. Regulatory intelligence can unlock the world.

Regulatory knowledge can expand a market. Regulatory intelligence can unlock the world.

In every pharmaceutical or biotech project, mastering the regulatory steps is key to saving money and time to market. And by outsourcing your global project to us, you create business opportunities all over the world.

We transform vast experience, our Swedish regulatory heritage and in-depth business intelligence into new opportunities for you. By treating your regulatory affairs as a business critical factor, we identify possibilities that may positively influence your project’s path to authorization – or the product’s life cycle once approved. That’s more than good business. It’s intelligent business.

Development Regulatory Affairs

Bridging regulators and science

Have you chosen the right indication and dose for your product? Is your documentation fit and ready for submission?

Reliable regulatory expertise and robust authority liaison experience from early development and onwards are essential factors for the commercial success of any pharmaceutical project.
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Head Office Regulatory Affairs

The power of outsourcing

Whether your need is within product development, market introduction or maintenance, our dedicated team of experts is ready to take full responsibility for your project’s every need. Our foresight and knowledge of the ever-changing pharmaceutical landscape will make sure you stay one step ahead. Outsourcing your pharma project to Sofus will allow you to remain focused on your core business.
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Regulatory Affairs - Local Markets

You don’t have to know the market. We do.

By being updated on the ever-changing regulatory landscape on your local market, you look into the future. You are prepared to take the right actions at the right time. A reliable, local regulatory expertise saves you time and resources, since even small regulatory issues may grow into big problems if not handled properly. Our Swedish regulatory heritage and our Nordic expertise combine to help you stay ahead and identify and act upon new possibilities that may positively influence your business.

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Quality and Compliance

Success is all about quality

Placing a product on the market requires taking responsibility and a rooting in both international and local regulations and environments. Your quality and compliance systems need to verify and guarantee a good quality of the product and ensure security for the patients. Perhaps you need a wholesale dealers’ authorisation, or need to perform a self-inspection or audit?

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Pricing and Reimbursement

The value of the right price

Rapid access to the market depends on a strategy for price and reimbursement and early communication with national and local payers. The local Nordic regulations and practices that affect pricing are increasing in complexity, with special situations arising for orphan drugs, products with restricted reimbursement and/or special conditions connected to the reimbursement decision, drugs with upcoming generic competition, and so forth.

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