Lausanne is one of the most qualified CRMOs supporting the health care industry today. It offers a broad complement of services supporting drug candidates and products from early clinical phases to market. Lausanne also supplies quality Active Pharmaceutical Ingredients (APIs) and advanced intermediates for clinical development candidates and commercial products.

• Sharp Solutions^®

We identify and implement creative solutions to solve chemistry and process issues for our clients from major pharmaceutical, new andemerging, and virtual pharmaceutical companies. We tailor our solutions to the client needs based on the phase they are in and their ultimate goal. We focus on cost-effectiveness in all of our solutions providing what the client needs not what would be nice to have or fits our equipment, technology, and revenue growth.

• Innovative Chemistry and ESPRIT Processes

Lausanne offers a complement of un-paralleled demonstrated chemistry creativity and process expertise supported by its highly experienced degreed staff that is unique in the industry. We have successfully:

• Generated 33 patents for our clients creating value in their programs ranging from process protection to competitive pricing advantage and life cycle management.
• Discovered, developed, and implemented economical processes saving our clients significant sums of money from the early clinical development phases.
• Positioned our clients to provide a competitive advantage in the face of generic competition

• Adaptive and Client-oriented Approach

Lausanne has created long-term relationships with most of its clients over the years as a result of being adaptive and responsive, delivering quality on time, and creating value. The business growth has been supported solely by these principles and recommendations and referrals of our clients over the years. We,

• Steer client processes clear of future roadblocks such as proprietary technologies, specialized equipment, and esoteric conditions.
• Apply our ESPRIT principle in all of our process efforts:
  
• Support technology transfer based on client needs.

• Confidence

We have developed an envious track record of creativity and innovation. We are willing to assume risk in creating value for our clients.

• Simple Relationships

Client owns what it pays for…Intellectual property, Records, Procedures, Methods, and Materials.

• Pre-clinical & Discovery Support

A limited focused client-specific service for Discovery and Pre-clinical activities…

• Analogs
• Advanced building blocks
• Reference materials
• Methods development

• Process Research

We apply our wealth of chemistry experience across all therapeutic areas and classes of molecules to…

• Identify and implement quick process improvements in early phases of clinical development to support scale-up without impacting the delivery timelines.
• Discover and demonstrate innovative complete synthesis routes that are:
• Practical and scalable for late phase development
• Economical for competitive price advantage
• Not tied to proprietary technologies
• Create Intellectual Property for our clients and put them on a better foundation for the market.

• Process Development

We use a methodical approach to generate the best process solutions that encompasses all of the critical disciplines…

• Chemical Development (click for details)
• Chemical Engineering (click for details)
• Analytical Development (click for details)

• GLP Tox and Form Batches

We support the pre-clinical development phase with timely delivery of quality API.

• Clinical Supply

First and foremost is getting your API to meet your clinical timelines. Although effort may be required to handle scale-up issues, we have historically overcome these challenges to meet tight delivery timelines.

• Commercial Production

• Commercial Manufacturing:
  • Batches for qualification, validation and launch
  • Batch isolation of up to two (2) metric tons per batch
• Cryogenic Manufacturing
• High-Pressure Manufacturing
• Filtration, Drying, Milling, Blending
• Cytotoxic and Potent Compound manufacturing
• Controlled Substance Manufacturing

• Stability Studies

• Fully Qualified Chambers
• Qualified (IQ/OQ) Alarm Notification System
• Restricted Access
• Dedicated Stability Manager and Staff

• Regulatory Support

• Robust Quality Systems that continuously evolve and improve to conform to current Good Manufacturing Practices, industry regulations and guidances.
• Commitment to providing quality products and service to meet the client's needs
• Effective communication and shared responsibility with the client ensures quality at every stage of the project
• Regulatory compliance and development support from pre-clinical to registration and commercialization

• Product Life Cycle Management

We believe in competitive advantage driven by creative process technology not low labor rates. We have demonstrated our ability to create alternative solutions for the life cycle management of client products.