About you
Whether your life science product is on the market or in development, you are faced with a complex regulatory landscape that presents both challenges and opportunities. Success requires the right expertise to manage risks, ensure compliance, and unlock potential. Let’s explore how we can help you move forward!
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Compliance expertise for Marketing Authorisation holders
Smarter compliance for stronger business
In the ever-changing regulatory landscape, the need for support might rise urgently.
We offer regulatory expertise to fuel your projects. Starting immediately.
- Global regulatory project manangement
- Marketing Authorisation Application (MAA)
- GMP compliance and audits
- Variations and lifecycle management
- Expansion into new markets
- GDP and supply chain
- Mergers, acquisitions, and due diligence
- Technology transfer
- Pharmacovigilance
- Market Access
Development services
We help drug development companies from lab to market, offering crucial support with Regulatory Affairs, CMC, Quality Assurance and Market Access. Make sure your product’s value is not lost in translation.
- Regulatory strategy
- Interactions with authorities
- Investor communication
Business expansion services
Commercialisation services with a joint mindset of business strategy and regulatory affairs. We help improve your business case, from development to launch and expansion.
- MAA services
- Strategic management consulting
- Geographical expansion
- Nordic expansion
Market specific services
Local intelligence for informed strategies and efficient operations. Our specialised team helps affilites succeed.
- Nordic regulatory affairs
- Market Access services
- Pharmacovigilance support
- GDP support
About us
We help leaders and companies in pharma and biotech realise projects and reach goals. Your starting point is where we begin. Achieving your desired goal scenario is our idea of success.
2020
Founded in Stockholm 2020. Read more about who we are.
40
A growing team of experts. Meet our people.
+100
Projects in the last year. Learn more about what we do.
19
Fluency in 19 languages.
+500
Over 500 hours/year of training and knowledge sharing.
