NexGen Logo

Pharmaceutical, Biotech, and Consumer Products Consulting

We offer problem-solving expertise in the areas of operations, manufacturing and CMC, quality systems, development, logistics, and other related specialties. We will guide you along the crucial steps of commercialization, from development to launch and adoption of your product.

Logos of NexGen clients.
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The NexGen
Approach

We realize that each company and each problem is different, and we don’t treat our clients with a one-size-fits-all approach. Rather than forcing clients into a preset contract with a minimum number of hours, we devise a specific action plan and propose an arrangement that best fits the client’s goal to complete the project on time and within budget.

We go beyond problem solving by teaching and advising our clients along the way, so they are better equipped to address similar technical and business issues in the future. This instructive approach to consulting sets us apart from other companies and is one of the reasons we have built a base of satisfied clients that continue to bring us new and unique challenges.

Our Specialties

NexGen Consulting Group can help your organization achieve success in areas such as:

Operations
Manufacturing
Product
Launches
Product
Development
Contract
Sourcing
Regulatory
Compliance
Quality
Assurance
Quality
Control
Validation
Legal
Counsel
Contract Drafting
& Negotiation
Data
Privacy
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Case Studies


Case Study 1

First Product Commercialization

Client Challenge

Many start-up biotech companies work hard to gain market approval from the FDA, and a lucky few bring a New Drug Application (NDA) or Biologics License Application (BLA) filing to conclusion before funding runs out. A small venture capital funded biotech successfully navigated through the complex drug approval process and received approval to market its first product.

However, the company soon realized it was completely lacking in plans and capabilities to support the commercial launch of its new drug. Worse still, shareholders were placing intense pressure on this small team of researchers to get the product launched quickly so that shareholder returns could begin to be realized.

NexGen Solution

The client turned to NexGen Consulting Group, which helped plan and execute every phase of the launch. NexGen formed and led a multidisciplinary team that brought the product to successful commercialization in a matter of weeks, as opposed to the 12 to 18 months typically required for a commercial launch. Drawing from vast launch experience, NexGen supported activities such as:

  • Setting up production and warehousing facilities
  • Managing logistics for primary and secondary labeling
  • Establishing an advertising plan
  • Pursuing reimbursement policies
  • Results

    Having in-depth experience in all phases of product development and launch, NexGen was able to execute on an aggressive timetable that required many overlapping tasks to be accomplished. This first launch was successful in reaching the market, and the client brought NexGen in to assist with its second product launch. The company is now a leader in its field, having beaten the difficult odds in the biotech industry.

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    Some of our clients

    Client logo of Biogen
    Client logo of Corgentech
    Client logo of Elan
    Client logo of InterMune
    Client logo of LG Life Sciences
    Client logo of Abgenix
    Client logo of Kodak
    Client logo of Salix
    Client logo of Phenomix Sciences