Many life science companies are facing increasing pressure of minimizing costs while ensuring innovation remains competitive. This often means sacrificing key resources that aid in the growth of healthcare products. Rubix helps pharma & biotech companies bridge the resource gap by being an active partner in various areas of their business.
Advisory & Consulting
Whether you need a more in-depth analysis or a dedicated team to plan, manage & execute a project, our experts can help you stay on track. We also provide an advantage with our knowledge & experience with federal regulations.
At our core, we are scientists, innovators, engineers and strategists who have failed our way to success. We are developing technologies that will eradicate rare diseases worldwide.
Hiring qualified personnel has grown increasingly difficult, as we know first-hand. Our placement services reduce the wait time of finding qualified people so that you keep momentum on projects that matter most to you.
HOW WE ENGAGE
Navigating Regulatory Compliance
On the quest to push the boundaries of innovation to develop and launch new products, companies have to address an increasing number of regulatory requirements which span multiple geographies, business activities and functions. While the life sciences industry has sustained growth and advances by drafting scalable compliance and business strategies that are flexible to the legal landscape, they continue to face challenges in growth, quality, and overall compliance.
Data & research
Anticipating what’s next
In the ever-changing healthcare landscape, innovation is what keeps companies at the forefront of patient’s needs. But before a product can mitigate the red tape of clinical trials and regulatory affairs, their product must first show credence and that begins with viable data and research.
Product Market Research & Analysis
- Qualitative & Quantitative research
- Disease trends and outlook briefs
- Competitive intelligence (US & emerging markets)
- Domestic & international compliance
- Analysis of regulatory reference documents
- Summary of procedures and requirements
- PMA: Annual Reports
- Initial Application 30 day – 135-day notices
- De Novo
- Panel Review
- RFD Review
- IDE Request
- Part to Part Configuration
- High-flow analysis
- Design for Manufacturing (DFM)
- Assembly modeling (Mechanical, electromechanical, electrical and fluid)
- Manufacturing scope (all life-cycles)
- Validation (Process/Equipment)
- Quality Engineering
- cGCP, cGLP and cGMP engineering
- Project/Program Management Engineering
- Risk Management Engineering
Turning ideas into innovation
Cost-effective. Results driven. Patient-centered. These are just a few of the qualities that any healthcare product should embody and in order to do so, life science companies need a knowledgeable and experienced partner to help bring their vision to life. This is why here at Rubix we help you engineer your product from simulation all the way through manufacturing.
research & development
Enabling products of tomorrow, today
In this technology-dependent era, R&D plays into cross-functional areas that directly impact company’s bottom lines. This is why Rubix focuses on creating a robust R&D strategy that takes into account the entire R&D life cycle which helps our clients develop a thriving pipeline portfolio while addressing dependency gaps.
- Sterilization studies
- Biocompatibility testing
- EMC testing
- Design Control
- Pharmacovigilance / Drug Safety
- Proactive Post Market Surveillance Plan
- Clinical Evaluation and Follow Up
- Study Design
- Medical Affairs
- API Development
- Design Thinking
- Rare Diseases
- Clinical Health Information Management
Hiring challenges are on the horizon
Global health care spending is expected to reach $8.7 trillion by 2020 due to emerging market expansion, advances in medical treatments, growing populations, and rising labor costs. This means that life science companies have to start building teams for tomorrow, today.
Unfilled positions are gaps in your strategy