Regulatory services in drug development

From idea to CTA, and beyond

Science and business go hand in hand. We support communication between scientist, authorities, and investors to ensure that the value of your product is not lost translation. Regulatory compliance is key for building a strong business case. 

A bridge in Rotterdam with buildings in the background, symbolizing the connections and pathways Arex Advisors creates in the pharma industry.

Get ready to meet the pharma stakeholders

Make the right decision for your drug development project

We will be your trusted partner bringing your idea to life, supporting you through the vital steps towards market introduction of your product. 

Translating your scientific vision into the language of investors, authorities and payers is a delicate exercise. There are strategical opportunities, only spotted by the experienced eye. Getting expert support in preparing for discussions with investors and getting ready for due diligence is a wise investment. 

Early phase services

Your project is unique. We know that. This is why we carefylly assess and select the components to create exactly the support setup you need for your journey. Arex offers a wide range of services, with the benefit of experts and specialists being brought into your project exactly when needed.

Regulatory strategies

  • Regulatory strategy plan
  • Scientific advice
  • Target Product Profile (TPP)
  • Quality Target Product Profile (QTPP)
  • Risk assessment

Regulatory pathways

  • Regulatory timelines
  • Orphan Drug Designation
  • Pediatric Investigational Plan (PIP)
  • PRIME designation

Regulatory support

  • Project management
  • Documentation management
  • Publishing support
  • Agency interactions

Clinical trials

  • Clinical and product development
  • IMPD writing
  • Medical writing
  • IMP labelling
  • CTIS submission

CMC strategy and support

  • CMC development plan 
  • Formulation development strategy
  • Analytical method validation advice
  • Impurity profile and spec limits
  • Tech transfer support
  • Combination product development

Early market access

  • Landscape review
  • Unmet need
  • Market potential

Investor/Exit strategies

  • Due diligence readiness
  • Gap analysis
  • Supply chain robustness
  • Quality data room setup and maintenance
  • Workstream leads

QA support

  • Validation/qualification
  • Document management systems
  • Self-inspections
  • Acting QP services

Supplier management

  • Audits (GMP, GLP, GDP)
  • Quality agreements
  • Tech transfer support

Training

  • GXP overview
  • GMP (in depth)
  • GLP (in depth)
  • GDP (in depth)

QMS

  • SOP writing
  • Offer for small startups: Small efficient fit-for-purpose QMS
Your contact person

Erik Hedner

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

Contact us

Linkedin

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.