# NexGen Consulting Group

> NexGen Consulting Group provides consulting services to the pharmaceutical, biotech, and consumer products industries.

NexGen Consulting Group provides specialized consulting services to pharmaceutical, biotech, and consumer products industries. We offer problem-solving expertise in operations, manufacturing, CMC, quality systems, development, logistics, and related specialties, guiding clients through commercialization from development to launch and product adoption.

## Our Approach

We recognize that each company and problem is unique, avoiding one-size-fits-all solutions. Rather than forcing preset contracts with minimum hours, we devise specific action plans and arrangements that best fit each client's goals to complete projects on time and within budget.

We go beyond problem-solving by teaching and advising clients, equipping them to address similar technical and business issues in the future. This instructive consulting approach sets us apart and has built our base of satisfied clients.

## Specialties

NexGen Consulting Group helps organizations achieve success in:

### Core Services
- Operations
- Manufacturing
- Product Launches
- Product Development
- Contract Sourcing
- Regulatory Compliance
- Quality Assurance
- Quality Control
- Validation

### Additional Expertise
- Legal Counsel
- Contract Drafting & Negotiation
- Data Privacy

## Case Studies

### Case Study 1: First Product Commercialization
**Challenge**: Small biotech with FDA approval but lacking commercial launch capabilities and facing shareholder pressure.
**Solution**: NexGen formed and led multidisciplinary team, executing launch in weeks rather than typical 12-18 months.
**Results**: Successful market entry, client became industry leader, engaged for second product launch.

### Case Study 2: Limited Manufacturing Resources
**Challenge**: Large consumer products corporation lost contract manufacturing for unique dosage form with few global vendors.
**Solution**: NexGen leveraged supplier network to develop new vendor source and managed complex manufacturing transfer.
**Results**: Timely vendor transfer with no supply interruption, maintaining market stability.

### Case Study 3: Bridging Cultures During Manufacturing
**Challenge**: US biotech and Japanese pharmaceutical partnership with cultural barriers and specialized dosage form challenges.
**Solution**: NexGen served as cultural liaison, reconfigured production, sourced equipment, trained 200+ employees.
**Results**: Complex project stayed on schedule, meeting tight manufacturing timeline within budget.

### Case Study 4: Complex Manufacturing Issues
**Challenge**: Biotech needing platinum-based ingredient production for clinical trial with explosive material concerns.
**Solution**: NexGen facilitated CMO relationships, consulted chemistry experts, improved yields and timelines.
**Results**: Drug product delivered on time for scheduled clinical trial, enabling continued product development.

### Case Study 5: Development Path Strategy
**Challenge**: Food company wanting to extract chemicals for pharmaceutical development.
**Solution**: NexGen recommended dietary supplement path instead of prescription pharmaceutical route.
**Results**: Successful natural supplement launch with strong market acceptance.

## Client Portfolio

Notable clients include major pharmaceutical and biotech companies:
- Biogen
- Corgentech  
- Elan
- InterMune
- LG Life Sciences
- Abgenix
- Kodak
- Salix
- Phenomix Sciences
- Teikoku Pharma

## Contact Information

- **Phone**: (831) 594-5056
- **Email**: info@nexgen.org
- [Home](https://nexgen.org/): Pharmaceutical, biotech, and consumer products consulting expertise.