Medical Device Manufacturers
Lone Mountain Biotechnology and Medical Devices, Inc
9885 Kraft Ave, Las Vegas, NV 89129, United States · Manufacturing companies in Las Vegas
- Contract manufacturer / job shop
- Founded 2008
- GMP
About Lone Mountain Biotechnology and Medical Devices, Inc
Lone Mountain Biotechnology and Medical Devices, Inc. was founded in December 2008 by Dr. Robert L. Garnick in Las Vegas, Nevada. Dr. Garnick brought over 25 years of experience Genentech's regulatory and quality organizations, where he was responsible for the approval of more than 17 drugs. The company began as a consulting practice leveraging that expertise to assist pharmaceutical and biotechnology clients with drug and device development. The firm provides consulting services across clinical and CMC regulatory affairs, quality control and assurance, and cGXP compliance (including GCP, GLP, and GMP). It also operates a prototype device development capability using AutoCAD for design and Haas CNC equipment for machining. Services span drug development portfolio evaluations, IND/NDA/BLA preparation, manufacturing site evaluations, comparability studies, FDA advisory committee support, and due diligence reviews for investors. The company additionally offers clinical trial design, pre-clinical studies, process sciences, analytical methods development, and biosimilar development support. Lone Mountain serves the pharmaceutical, biotechnology, and medical device industries. Its client base ranges from large pharmaceutical companies to early-stage start-ups, as well as investors seeking due diligence on manufacturing capabilities and CMC sections of regulatory filings. The company has facilitated numerous FDA Type C meetings and has worked with three clients on biosimilar development programs, including cell line and process development. The company differentiates itself through a network of senior consultants—former Genentech colleagues—who collectively have brought over 17 drugs to market. This "Dream Team" provides rapid resolution of complex drug development issues, FDA meeting facilitation, and biosimilar pathway strategy. The prototype machining capability allows clients to move from design to G-code and physical prototypes in-house.
Manufacturing capabilities
Core processes
Inspection & quality
Industries served
- Pharmaceutical
- Biotechnology
- Medical Device
Equipment
- Haas CNC machines
- AutoCAD
Company details
- Location
- Las Vegas, Nevada
- Company type
- Contract manufacturer / job shop
- Founded
- 2008
- Certifications
- GMP
- Listed under
Frequently asked questions
Where is Lone Mountain Biotechnology and Medical Devices, Inc located?
Lone Mountain Biotechnology and Medical Devices, Inc is located at 9885 Kraft Ave, Las Vegas, NV 89129, United States.
What does Lone Mountain Biotechnology and Medical Devices, Inc do?
Lone Mountain Biotechnology and Medical Devices, Inc is listed under Medical Device Manufacturers, and its listed capabilities and products include Drug development project portfolio evaluation, Manufacturing site evaluation for regulatory applications, Comparability study design and execution, FDA advisory committee planning and rehearsal, Validation strategy for analytical methods and manufacturing processes and cGXP, cGMP, cGLP inspectional support.
What industries does Lone Mountain Biotechnology and Medical Devices, Inc serve?
Lone Mountain Biotechnology and Medical Devices, Inc lists Pharmaceutical, Biotechnology and Medical Device among the industries it serves.
What certifications does Lone Mountain Biotechnology and Medical Devices, Inc have?
Certifications on file for Lone Mountain Biotechnology and Medical Devices, Inc: GMP.
When was Lone Mountain Biotechnology and Medical Devices, Inc founded?
Lone Mountain Biotechnology and Medical Devices, Inc was founded in 2008.
How do I request a quote from Lone Mountain Biotechnology and Medical Devices, Inc?
Use the Request a quote button on this page to send Lone Mountain Biotechnology and Medical Devices, Inc your requirements through FirmsLedger, or call (650) 863-3589 and visit lonemountainbiotechnology.com.
What companies are similar to Lone Mountain Biotechnology and Medical Devices, Inc?
Other Medical Device Manufacturers in Nevada listed on FirmsLedger include New Deantronics, Advanced Medical Device Technologies, Inc. and MK Fluidic Systems.