HomeAbout UsServicesContact Us

This site  The Web 

9885 Kraft Ave. Las Vegas, Nevada 89129

Phone- 702-655-9924, cell 650-863-3589 or Cell#2 650-504-8806


email-  garnickrob@lonemountainbiotechnology.com

email- alternative- garnickrob@aol.com

email- ggarnick@yahoo.com


Lone Mountain Biotechnology -Latest News and Updates

Following an extremely successful year in the Professional Consulting Business, which has included experience with over 15 different clients ranging from Large Pharmaceutical companies to small start-ups, we have learned that we can provide unique capabilities to the pharmaceutical industry. 

During this last year, Lone Mountain has developed close relationships with a number of highly experienced professionals who have agreed to sub-contract through Lone Mountain in the following areas: Clinical Trial Design and Implementation, Pre-Clinical Studies, Process Sciences, Analytical Methods Development, GXP Compliance, Comparability Studies, Stability Studies, Virology, Microbiology, Marketing, and Regulatory Affairs.  Each of these Consultants has personally worked with me during my 25 years of successfully leading Genentech's Regulatory and Quality Organizations, and has a proven track record!

Working with a number of clients this group including myself has very effectively assisted clients in rapidly resolving highly complex issues involving Drug Development. We work to gether efficiently and collaboratively focusing our attention on your specific goals. The experience of working once again with this group of consultants has proven to be both enjoyable and incredibly effective. The client effectively gets access to a "Dream Team" of professionals who have previously brought over 17 drugs to the market over 25 years. Please go to the "ABOUT US" page of this website to see the list of Lone Mountain Consultants.

Over the last year we have facilitated numerous "type C" meetings between our clients and the FDA.  These meetings have proven to be incredibly valuable. In these meetings clients in various early stages of drug development are able to provide key information to the Agency and based on this information package, ask FDA critical questions about their drug development programs. FDA has been both gracious and timely, giving the clients invaluable insights, and guidance into how best to configure their programs and their resolve issues. Written responses to the clients' questions are provided by the agency in a timely manner, and often serves as a valuable first introduction for the client into the Regulatory Drug Development process. The clients who have availed themselves of these meeting have come away with invaluable information, and a good sense of how the agency thinks and operates.

We have also been highly involved in the development of various Biosimilars over the past year with three different clients. We have learned that molecular differences do occur when cell lines and processes are changed, but that these differences can be readily adjudicated. We have been successfully involved in cell line development as well as process development for a number of Biosimilar candidates, and have made presentations, which are available on request.

Now that the new health care legislation includes a pathway for Biosimilars in the US we will be representing clients to the FDA with respect to how to best develop a Biosimilar Development Pathway including Clinical and CMC requirements.

10:36 am pdt 


Link to web log's RSS file

A view of Lone Mountain.NV
(Click to enlarge.)

Lone Mountain Biotechnology and Medical Devices is a company specializing in Drug and Device development.  We offer consulting services in the areas of Clinical and CMC Regulatory affairs. Quality Control and Quality Assurance for Drugs, Biologics and devices and all aspects of cGXP Compliance including GCP,GLP and GMP. In addition we can provide expertise in Drug and Biologics promotional activities. Lone Mountain Biotechnology also provides experimental and Prototype level device development capability with state of the art AutoCAD  and CNC prototyping capability using Haas equipment.

Our services include:
    • Drug Development Project Portfolio evaluations
    • Regulatory Affairs- IND, NDA , BLA and CTX preparation and review
    • Promotional material review
    • Manufacturing site evaluations for IND's, NDAs and BLA applications
    • Comparability study design and execution including regulatory support and FDA defense strategy
    • FDA Advisory committee planning, rehearsals and execution
    • Validation strategy for Analytical Methods and Manufacturing Process design and support
    • cGXP,cGMP and cGLP Inspectional support and strategy development
    • Strategy development for new manufacturing sites
    • FDA/EMEA review interactions management
    • Medical Device development strategy and execution
    • AutoCAD Device development to G-code level
    • Prototype Device design and development
    • Prototype to manufacturing strategic plans
    • Due Diligence Reviews of Companys Manufacturing Capabilities and Capacities for Investors
    • Due Diligence reviews of Chenistry Manufacturing and controls sections of CTD's for Investors
    • Evaluation and resolution of Warning letters and Consent Decree issues for companies as well as third party evaluations and Control for Regulatory resolution of these situations


We are proud members of the following organizations:
Northeastern University, Barnett Institute- Adjunct professor
Las Vegas Chamber of Commerce
American Chemical Society