Advisory & Consultation

Life-science companies are increasingly prone to more failures as the market is churning toward new development efforts needed. As companies shift toward development, many of the product development efforts face the following:

Project Management and Planning

Although many business consultants can put together a basic business plan, few have the technical background in biotech or advanced systems development to account for vagaries and external forces that affect bringing a product from concept to production. Our project management team can supplement your in house skill set and put you on track for a successful product development cycle.

Regulatory

Regulatory compliance is a maze that can often make or break a product or a company. As devices transform, so does the landscape of how regulations monitor and govern how they interact with the market and with the patient populations. We have fostered relationships with regulatory agencies to help provide guidance and industry adoption on the next level of device efficacy measures to ensure that we’re creating a world free of disease for the future. 

COMPETENCIES

MEDICAL DEVICES

  • IDE 

  • PMA: Annual Reports 

  • Initial Application 30 day – 135-day notices

  • 510k 

  • De Novo 

  • IVD

PHARMA

  • NDA 
  • BLA 
  • IND 
  • Xenotransplantation 
  • Vaccines 
  • PMA

COMBO PRODUCT

  • Panel Review 
  • Pre-RFD
  •  RFD Review 
  • IRB 
  • IDE Request

CASE STUDY

PROBLEM

A Massachusetts based CRO was in the process of managing and developing a few new IND (investigational new drug) projects for their Fortune 50 pharmaceutical customer.  Part of the scope was, not only to manage the development progress but to also engage the stakeholders to begin pre-clinical and clinical work in the laboratories.  A preliminary project review plan was evaluated and revealed that for the specific targeted area focused on cardiovascular of the drug development plan, highlighted that the CRO did not have accreditation toward managing this area for patients. Rubix LS was tasked as the consultant subject matter experts to aid the discovery dissemination to the Principal Investigator (PI) that enabled approval clinical site approval for IRB compliance. 

SOLUTION

Rubix engaged the CRO’s clinical operations and biological departments to bridge communication gaps and formulate an interdependent project management plan. This allowed the project timeline to become lean and ensured no task could be completed without the previous one being fulfilled.  This concentrated effort localized the ambitions of the executive team to be fully invested in the project’s progress beyond their traditional management responsibilities and due to the simplification of the project plan, the executive team was highly motivated to complete some of the work themselves.

RESULTS

Rubix helped the CRO mitigate errors throughout the project and effectively bridge communications between interdependent departments.  As a result, the CRO was able to qualify as a clinical site study, from the FDA and IRB committee, for longitudinal studies in the use of interventional cardiology measures for invasive surgical techniques.

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