Calcott Consulting has just completed a series of webinars and
presentations at national meetings on the following topics:
If you would like to learn more about these topics, contact us for a
consultation.
SUCCESS STORIES
During the last two years we have helped our clients to accomplish some
significant milestones. Some of the highlights include:
1. License a device with the FDA and implement a supply chain and
quality systems for launch
2. Transition a Device company to full FDA compliance as regulations
changed and products reclassified
3. Develop and implement a QMS for a small biotech company as it
grew and faced regulatory challenges
4. Developed a Computer Validation Program for a small biotech
company
5. Developed a simpler, cheaper yet compliant start-up plan for a
small biotech company
6. Develop a Quality Strategy and Quality Manual for a small biotech
company
7. Develop and implemented a training program to transition a
research group into GLP compliance and operation
operations
8. Brief a Japanese Pharmaceutical Company on strategies to work
with the FDA as they launch products in the US.
presentations at national meetings on the following topics:
- Quality by Design
- Preparing for an Unannounced Regulatory Inspection
- Process Validation - Planning & Implementation
- Monitoring and Auditing Clinical Trials Sites
- Preparing for a Pre-Approval Inspection
- How to Develop a Compliance/Governance program
- E-solution Implementation - avoiding the costly time
consuming mistakes - Managing Contract Manufacturers in your Supply Chain
If you would like to learn more about these topics, contact us for a
consultation.
SUCCESS STORIES
During the last two years we have helped our clients to accomplish some
significant milestones. Some of the highlights include:
1. License a device with the FDA and implement a supply chain and
quality systems for launch
2. Transition a Device company to full FDA compliance as regulations
changed and products reclassified
3. Develop and implement a QMS for a small biotech company as it
grew and faced regulatory challenges
4. Developed a Computer Validation Program for a small biotech
company
5. Developed a simpler, cheaper yet compliant start-up plan for a
small biotech company
6. Develop a Quality Strategy and Quality Manual for a small biotech
company
7. Develop and implemented a training program to transition a
research group into GLP compliance and operation
operations
8. Brief a Japanese Pharmaceutical Company on strategies to work
with the FDA as they launch products in the US.
WHO ARE OUR CUSTOMERS?
You have been small start ups, a mid sized R&D companies, venture
capitalists and mature pharmaceutical companies.
Review the tabs ABOUT US and SERVICES to learn how we can help you.
We can supply:
You have been small start ups, a mid sized R&D companies, venture
capitalists and mature pharmaceutical companies.
Review the tabs ABOUT US and SERVICES to learn how we can help you.
We can supply:
 | Temporary resources to augment your staff | |
| Executives to lead specific functions | |
| Expertise to develop long range strategies and help to execute them | |
| Resources to develop and execute projects where you do not have | |
| full time resources | ||
| Benchmarking skills to evaluate different strategic options | |
Calcott Consulting is an experienced and dedicated consultancy service that is completely customer focused and
objective, and specialized in biotechnology/pharmaceutical industry. Calcott Consulting utilizes best practices to
provide you 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.
objective, and specialized in biotechnology/pharmaceutical industry. Calcott Consulting utilizes best practices to
provide you 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.
Calcott
Consulting
Consulting
What's new?
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| "your success is our success" |
| Peter (510) 585-8256 Kelly (408) 216-3655 |