Compliance and business support for life science product development
Product development
Science and business go hand in hand. We support your product development with the end goal of market entry in mind. Regulatory compliance is key for building a strong business case in pharma, biotech, and medtech.
We also support communication between scientists, authorities, and investors to ensure that the value of your product is not lost translation.
Get ready to meet the pharma stakeholders
From idea to CTA, and beyond
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 Market Access strategy
Whether you are planning to market your product after approval, or to divest it, your strategy should include a Market Access perspective. Early alignment of commercial strategy with regulatory and clinical development, will help you optimise pricing outcomes and patient access.
Read more about Market Access in pharma development:
Early market access strategy
HTA/reimbursement submission strategy
Market landscape review
Early phase pharma services
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
Strategic advice and operational support in Medtech development
Bringing your Medtech innovation to life
Arex offers bespoke solutions to help you navigate the complex global regulatory landscape and approval process, ensuring that you develop safe and compliant medical devices that are ready for market entry.
Early phase Medtech services
We guide you through the essential stages of the product development journey ensuring the development of compliant and safe products that meet their intended use. Our product development support offers you expert guidance in Design Control, Risk Management, Usability Engineering, and other crucial areas in regulatory and quality compliance.
Read more about our services:
Your contact person
Nelly Fransén
