Offering Industry Insights and Client-Centric Collaborations

  • Biopharmaceuticals
  • Medical Devices
  • IVD
  • Investors

Our Commercial and Regulatory Consultants work with all levels of the organization. Developing goals with CEOs striving to meet stakeholder expectations, assisting functional support teams, and projecting market trends with investors looking to maximize corporate investment returns. We feel that these activities will directly impact an organizations success in the market.

Commercial and Regulatory STRATEGY

  • Product Positioning
  • Product Labeling Strategy
  • Early Development Planning and Prioritization
  • How and When to Commercialize
  • Indication and Portfolio Prioritization

Regulatory strategic Planning

  • Support clients developing biologics, small molecules, devices, biosimilars and combination products
  • Advise on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions
  • FDA Meeting Preparation & Engagement
  • Assist with preparations for FDA and Advisory meetings
  • Nonclinical and CMC development
  • CMC Audits

Global Market Access and Pricing Strategy – US & EU

  • Market Access and Reimbursement Strategy
  • Pricing and Contracting Strategies
  • Channel and Distribution Strategy
  • Patient Access Program Planning
  • Health Economics and Cost Effectiveness Modeling

New Product Planning

  • Product Evaluation & Target Profile Development
  • Market Assessment & Opportunity Sizing
  • Global Disease/Market Strategy
  • Launch Readiness Planning
  • R&D Investment Decision Guidance
  • Market Surveillance, Mapping, Planning
  • Commercial Organization Preparation

Value-based Experience for Confident Business Decisions

CELLANDTECH GROUP ’s business consultants develop thought-provoking insight and recommendations. Through our recommendations, we deliver measurable, high-impact, strategic road maps that can be deployed based on a client’s unique needs, capabilities and resources. Our structured and customized consulting methodologies increases the likelihood of client value by ensuring collaborative contribution from internal partners. By balancing the inputs and constraints against key business drivers, we leave clients fully equipped and empowered to enhance and sustain commercial success and benefits to patients.
We offer structured engagements as well as custom ad-hoc consulting in a number of
commercial related functional areas.

  • Structured Project - Oriented Engagements

    Individual or Team Provided

  • AD Hoc Advisory Services

    Retainer Arrangements and Access to Multifunctional Expertise

  • Executive Staff Augmentation

    Short-to-Long Term Assignments