Category: Our Services

Everything starts with a great idea. But a great vision needs thorough understanding of the real-world mechanics in order to make it real. Our management experience of successful fund raisings and exits helps you defining the right strategy. Your goal is to bring a life science innovation to the patient. We help you to establish the right framework to it. We take a holistic view on your product concepts and put your innovative idea into perspective. Market, technology, development plans and finance have to be orchestrated in order to present a sound and comprehensive case to your investors. Our special expertise: respiratory diseases and inhalation

• Business Plan Guidance and Checkups
• Financial Framework
• Accounting, Controlling and Reporting

Having fund raising completed, the work begins. We can relieve you from most administrative task which would only distract you from your core business.

• Accounting, Financial Statements
• Contract Management
• Business Plan Maintenance
• Financial Reporting to Investors and Banks
• Project Controlling and Budget Monitoring

A wonderful technical solution might solve your problem during the development phase. But it might not be the right one for the market? During the development phase, a lot of technical challenges occur which need your full attention. At the same time, regulatory, contractual, IP, manufacturability and costing aspects are critical for design transfer and industrialization. Not considering this right at the beginning means putting your business plan at risk by adding further development cycles. But who has the time to consider this? Our expertise can prevent typical strategic pitfalls during the development of medical devices.

• Regulatory Strategy, legal Manufacturer
• Functional Models Prototyping, Process Development, FMEA
• Clinical Evaluations
• Project Controlling and Risk Management
• Design Controls, Technical Documentation
• Interaction with Notified Body, Approvals

Activoris received the manufacturing and import license for secondary packaging of clinical samples. The authorization includes non-sterile drugs, biologicals, human or animal extracted products, hormones, prostaglandins, cytokines as well as immune-suppressives for phase I, II, and III clinical trials. Your trial is a challenging project, rely on our expertise to establish the right strategy regarding to purchasing, kit configuration and supply to your study centers.

• Flexible Project Support, Partner-Network for primary packaging
• Kit Configurations, Booklets, Package Inserts
• Cooling Capacities 2 – 8 °C, Hazardous Substances
• Packaging and Labeling, Kit Assembly
• QP Release, GMP compliant Conduct and Documentation
• Storage and Distribution

Medtech Studies

Today, the requirements for clinical trials gain more importance in view of the approval of innovative devices. However, a CE-marking or a 510(k) clearance is not enough to achieve sales. The increasing price pressure calls for a superior differentiation. Meaning, obtaining re-imbursement requires to effectively demonstrate superior performance of your device. Our medtech and pharma experience of multiple clinical developments and a specialized provider network navigate you through this important development step.

• Clinical Strategy and overall Coordination
• Tenders, CRO-Selection
• Manuals, Device Trainings
• Device Assembly
• Clinical Trial Logistics

At Activoris, we are driven by operational excellence and lean manufacturing. Based on the demand forecast scenarios, you can rely on us to develop a well-balanced manufacturing and supply chain management concept. Alongside, we continuously watch the potential for cost optimizations.

 

• Process and Test Design, Validations and FMEAs
• Pilot Series, Pre-Production, Scale-Up
• Supply Chain Management
• Implementation of Management Procedures (e.g. Sales & Operations Planning, SCM Risk Management, Contingency Plans)
• Service, Repair, Complaints