We are committed to regulatory affairs, market access and strategic business development.

 

If you are establishing or want to grow your life science business, we want to be the ones you talk to. We know your way around and can provide directions.

Drug Development and Medical writing

Making sure scientific and regulatory requirements are met during development is vital when taking a drug to market. Arex Advisor can help you by anticipating regulatory hurdles, minimizing requirements when possible and ensuring swift progress through the drug development process.

 

Our experienced team can provide guidance and support during drug development from early preclinical stage through the clinical phases up to submission.

Example of services:

  • Scientific advice support
  • Dossier development
  • Medical writing
  • Strategic regulatory advice

Want to know more?
Contact me!

Erik Hedner

+46 8 519 345 04

Email

Chemistry, Manufacturing, Control

CMC is a fundamental part of the drug development process. The manufacturing process, analytical testing and product characteristics must be adequately defined and controlled to ensure a consistent, safe and effective product. Incorporating CMC early in the process ensures that stringent product requirements from competent authorities are met and is critical to project success.

 

Pharmaceutical technology transfer can be a daunting task and require careful preparation and planning to be executed successfully and on time. We have experience with transferring manufacturing processes to third party contract manufacturers, scaling up for commercial production and helping clients setting up their first biobatch.

 

Arex Advisor can be your regulatory partner and support your CMC-related activities and technology transfer projects from start to finish.

Our consultants can support a range of CMC-related activities including:

  • Formulation strategy
  • Analytical validation advice
  • CMC account management
  • Documentation management
  • Upscale support and advice
  • Submission strategy and regulatory compliance

Want to know more?
Contact me!

Erik Hedner

+46 8 519 345 04

Email

Quality Assurance GMP

A GMP (Good Manufacturing Practice) compliant regulatory system to ensure the quality of the product is fundamental for any pharmaceutical company. The manufacturing process, analytical testing and product characteristics must be adequately assured and controlled to ensure a consistent, safe and effective product. Key elements are Quality Assurance and Quality Control which confirms that the quality requirements are being fulfilled and that the product safely can be released to the market.

 

Quality assurance plays a significant part in a technology transfer process that often includes unpredicted variables. Rigorous quality assurance ensures that variability of processes and parameters are controlled and appropriately adjusted. We have vast experience from managing successful technology transfer projects – from early planning and preparation to execution of the transfer.

 

Arex Advisor can be your quality partner and support your GMP-related activities and technology transfer projects from start to finish.

Example of services:

  • Analytical control and batch evaluation
  • Quality management system
  • Site transfer assessment
  • Technology transfer support and advice
  • Project management
  • Quality assurance strategy and GMP compliance

Want to know more?
Contact me!

Erik Hedner

+46 8 519 345 04

Email

Regulatory Affairs

Local presence, European expertise, global project management

Regulatory affairs is a crucial business function for any pharma or biotech company. It can be the difference that makes or breaks a project. 

 

Arex Advisor offers a full range of regulatory services. If you wish to optimize your regulatory affairs function, or perhaps have temporary increases in workload, you can rely on us to provide the solutions for your projects. We pride ourselves on our flexibility and want to ensure our clients have the best possible experience and tailored solutions that address their specific needs. 

 

Our regulatory experts have extensive experience from pharma industry as well as competent authorities and can provide both strategic regulatory advice and operational support. Projects are normally managed from our site, but if needed we can provide consultants for on-site tasks. 

Example of services:

  • Regulatory procedure management 
  • Dossier compilation 
  • Orphan drug applications/PIPs/PRIME 
  • Strategic advice 
  • Regulatory intelligence 
  • Due diligence and gap analysis 
  • Product information and labelling  
  • Local regulatory intelligence 

Want to know more?
Contact me!

Lovisa Rosenquist

+46 8-519 345 03

Email

Local Representative

Arex can act as the local representative for your products. Our experienced teams are experts on the Nordic markets, anwe have an extensive network covering the EU. We can ensure successful launches of products, meeting all local requirements.  

 

In addition to regulatory affairs and market access, we can manage other local activities needed for the successful maintenance of products on the markets, such as local pharmacovigilancemedical information and quality assurance

Example of services:

  • Product launch 
  • Review of promotional materials 
  • Readability tests 
  • MAH-transfers 
  • Complaints management 
  • Adverse events reporting 
  • Medical information 
  • Wholesale Distribution Authorization (WDA), including Responsible person. 

Want to know more?
Contact me!

Lovisa Rosenquist

+46 8-519 345 03

Email

Lifecycle Management

During a product’s lifecycle it will be subject to numerous regulatory procedures, ranging from the early applications such as orphan drug applications, PIPs and PRIME, to lifecycle events such as variations and extension applications.

 

We can guide you through the process and provide regulatory advice, as well as taking on full responsibility and handling both the strategic and operational aspects of projects.

 

Our regulatory experts have extensive experience from industry and competent authorities and know how to optimise the regulatory aspects of your products.

Example of services:

  • Variations and Line extensions
  • Regulatory Development plans
  • Exit strategies

Want to know more?
Contact me!

Lovisa Rosenquist

+46 8-519 345 03

Email

Market Access Strategy

Market access is a key step in a successful launch and optimal uptake of your product. By including commercial aspects early in drug development the chances of successful access and reimbursement for your product are increased. Early market access planning, payer-relevant evidence generation and value communication are important activities in the commercializing process and will significantly increase the likelihood of early patient access.

We offer a range of solutions to support early market access:

  • Market landscape review
  • Market access strategy
  • Payer value proposition development
  • Global value dossier development

Want to know more?
Contact me!

Susanne Schuurman

+46 8-519 345 05

Email

HTA and reimbursement

The payer landscape is becoming more complex and the demands of HTA and reimbursement agencies are increasing. Demonstrating the clinical and economic benefits of your product is crucial for payers to approve patient access.

 

We can help you demonstrate and communicate the value of your product to meet HTA requirements and gain reimbursement.

Example of services:

  • HTA scientific advice
  • Evidence submission strategy
  • Dossier development
  • Targeted literature reviews
  • Evidence adaptations to local context
  • Validate evidence with key opinion leaders

Want to know more?
Contact me!

Susanne Schuurman

+46 8-519 345 05

Email

Health Economics

Health economic models are important decision-making tools for authorities, experts and payers for prioritizing health care resources. To achieve market access and reimbursement, health economic modeling is often necessary.

 

We arrange support with health economic modeling and model adaptations to address payer needs. We can help with targeted and systematic literature reviews to provide input to value dossiers and economic evaluations.

Example of services:

  • Country model adaptation
  • Cost-effectiveness modeling
  • Cost-minimization modeling
  • Budget impact analysis
  • Literature review

Want to know more?
Contact me!

Susanne Schuurman

+46 8-519 345 05

Email

Portfolio Development and Commercialization

Portfolio development and commercialization are about expanding your market presence. Maybe you are looking for a new product to complement your existing product portfolio or you want to expand your range for a certain product. You may want to explore a new therapeutic area or need to contract a new CMO. Or perhaps you want to expand your territory and find the best partner for marketing your product.

 

Regardless if you a targeting a licensing deal, want to make an acquisition or find a new contract manufacturer. Arex Advisor has the experience to be your partner. We can help you understand and navigate the hurdles for a successful portfolio expansion all the way from market assessment through final negotiations.

Example of services:

  • Market potential landscaping
  • Acquisition or in-licensing candidate identification
  • Out-licensing partner evaluation
  • Due diligence
  • Commercial and technical contract negotiations
  • CMO search and tech transfer operations
  • Reimbursement/HTA evidence review and submission strategy

Want to know more?
Contact me!

Staffan Thunell

+46 8-519 345 01

Email