Calcott Consulting LLC is an experienced and dedicated consulting service that is completely customer focused and objective. It specializes in the biotechnology / pharmaceutical and the device industry arena. Calcott Consulting utilizes best practices to provide the most cost effective and efficient solutions to meet your needs. We will take on the tough tasks and give you the tough talk on what needs to be done.
During the last seven years we have helped our clients to accomplish some significant milestones. Some of the highlights include:
- License a device with the FDA and implement a supply chain and quality systems for its launch.
- Transition a device company to full FDA compliance as regulations changed and products are reclassified.
- Develop and implement a QMS for a small biotech company as it grew and faced regulatory challenges.
- Developed a computer validation program for a small biotech company.
- Developed a simpler, cheaper yet compliant start-up plan for a small biotech company.
- Develop a Quality Strategy and Quality Manual for a small biotech company.
- Develop and implemented a training program to transition a research group into GLP compliance and operation.
- Briefed a Japanese pharmaceutical company on strategies to work with the FDA as they launch products in the US.
- Developed a remediation plan and helped implement it for a company issued with a Serious Warning Letter
- Aided a major material distributor in designing a facility to meet 21st century standards.
- Developed and implemented a QbD program for a company to take advantage of the new direction in product development.
- Supplied supply chain expertise for the manufacture of a clinical candidate for a small virtual biotechnology company
- Served as an expert witness in litigation related to patent infringement between innovator and generic manufacturer
- Developed a compliance program for a newly commercial device company including code of conduct and anonymous reporting process.
- Developed a strategy for generic manufacturer to gain entry into the US market
- Evaluated and optimized a strategy to manufacture Phase I material in a facility concurrently with process development
- Aided a leading Japanese pharmaceutical company in improving their QMS in a cost effective manner
- Performed CMC due diligence in preparation for acquisition
- Assisted a service provider in developing a market expansion strategy in the pharma world
Who Are Our Customers?
They have been small start-ups, mid sized R&D companies, venture capitalists and mature pharmaceutical companies.
We can supply:
- Temporary resources to augment your staff
- Executives to lead specific functions
- Expertise to develop long range strategies and execute them
- Resources to develop and execute projects where you do not have full time resources
- Benchmarking skills to evaluate different strategic options