Analytical workloads are accomplished by highly skilled chemists
A critical component of any regulatory submission of a NDA or ANDA is the analytical quality package. At Lyne, our skilled analytical team develops and validates analytical methods to support the formulation process for finished products. An important advantage of partnering with Lyne Laboratories is the support provided by our analytical department. We strive to provide our Quality Control Department with innovative tools and systems in order to enable our scientists to manage their testing processes efficiently and accurately. We understand the development, testing, regulatory, and manufacturing challenges that have to be faced and we collaborate with our partners to ensure we achieve our development goals so we can bring our targeted products to market as quickly and efficiently as possible. Our laboratory staff is the perfect complement to our manufacturing expertise. Our well equipped laboratories maintain adequate modern analytical instrumentation for the purpose of remaining current with all compendia requirements. Lyne’s well-equipped laboratories and qualified chemists play an indispensable role in maintaining our on-time drug programs. Although we do not expect to list all of the services performed, below are some of the services routinely performed by Lyne Laboratories’ Quality Control Department.
Our Analytical Services:
- Methods Transfer
- Validation Services
- Microbiological Services
- Cleaning Validation
- Stability Services
- ICH Conditions:
- Accelerated
- Long-term
- Annual shelf life
- Surveillance
- Monograph Testing
- Process validation testing
- API testing
- Inactive ingredient testing
- Component testing
- Drug product testing