Important Update on Pharmatech Associates Operations

FRESH THINKING, BETTER OUTCOMES

Your products touch lives. At Pharmatech Associates, we help life science companies bring these products to market worldwide. Navigating this complex process requires technical expertise in Compliance, Product & Process Development, Regulatory Affairs, and Facilities & Capital Projects including Validation. This interconnected framework is the Pharmatech Ecosystem.

And that means better outcomes for your patients.

Our process

VALUE IN OUR PROCESS

The Pharmatech ecosystem is four foundational knowledge areas of product development: Compliance, Product & Process Development, Regulatory Affairs, and Facilities & Capital Projects including Validation. Our subject matter experts (SMEs) have fully integrated development understanding across these four areas. This translates to agile teams with deep understanding of drug and device development and allows us to respond with pragmatic solutions, proven systems, and industry best practices. We are a trusted advisor proudly serving clients for over 25 years.

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Our process

VALUE IN OUR PROCESS

The Pharmatech ecosystem is four foundational knowledge areas of product development: Compliance, Product & Process Development, Regulatory Affairs, and Facilities & Capital Projects including Validation. Our subject matter experts (SMEs) have fully integrated development understanding across these four areas. This translates to agile teams with deep understanding of drug and device development and allows us to respond with pragmatic solutions, proven systems, and industry best practices. We are a trusted advisor proudly serving clients for over 25 years.

Our process

PRODUCT & PROCESS DEVELOPMENT

Bringing a medical product to market is a complex undertaking. The product development processes require a proven, systematic approach that balances product quality, regulatory risk and stakeholder demands to minimize time to market.

Our process

FACILITIES & CAPITAL PROJECTS

We design facilities that work across the entire product development lifecycle from molecule to manufacturing and beyond.

Our process

COMPLIANCE

A regulatory compliance business relationship begins with a strong fiduciary bond. Partnering with a regulatory compliance expert gives you the insight and experience needed to ensure program success with regulatory authorities worldwide.

Our process

REGULATORY

Expert knowledge and experience matter during the regulatory approval process. Gaining approval requires a diligent scientific and statistical foundation upon which carefully structured and articulately drafted documents are used to make the case for your product’s rapid and successful approval.

WHAT'S NEW?

Our virtual booth at ISPE Annual Meeting is live. Visit us anytime or during the meeting on Nov 2-6, 2020. More News  

FRESH THINKING, BETTER OUTCOMES

The Pharmatech Difference

Bikash Chatterjee, President and Chief Scientific Officer, introduces you to the breadth and depth of knowledge and expertise possessed by our staff of Associates and SMEs at Pharmatech, and explains our unique approach to advising and providing technical services to our clients, that has been the basis for our decades of success in the Regulated Life Science industry.

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"Thank you again for endurance during the contract process, etc. From my view, the meeting finished in success, thank you for two wonderful members you have introduced to us. The Client felt that they were able to receive valuable comments surpassing what they have paid for."

- $19B JAPANESE GENERAL CONTRACTOR

"Pharmatech’s team has been a crucial element to the success of the project. Pharmatech was originally brought on to perform commissioning and qualification activities of the facility, utilities, and process systems related to the product. As the project commenced, Pharmatech’s engineers and project manager provided much more to ensure the project was completed successfully. Pharmatech became an integral member of our team, assisting with troubleshooting and creating solutions in order to complete the installation, optimization, and operation of key process systems. Most notably was a fluid bed granulator and solvent coater and their associated systems. I have very high praise for Pharmatech’s work as they not only execute the work well, but they also provide answers rather than wait for solutions to be presented to them during the course of the project."

- Johnson and Johnson Division

"Thank you so much for all you and your team's work in our facility, there is no way we could have done this without you."

- $200M COMBO DEVICE COMPANY

"Let me add my congratulations to the team; I have seen a tremendous effort in response to a very large challenge and it is gratifying to see the teamwork that has transpired to make this stretch goal. I want to particularly thank the Pharmatech team in addition to the other team members who have helped orient the quality-related issues and provide vision and solutions. Also thanks to the Pharmatech team who have been the paratroopers who have landed behind the lines and have helped corral our outstanding issues."

- ANONYMOUS

Contact Us

Pharmatech Associates, Inc.
22320 Foothill Blvd. Suite 330
Hayward CA 94541

Phone: 510.732.0177
Fax: 510.732.1992
TF: 877.787.0177

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Navigating the FDA’s Emergency Use Authorization Process

A graphic representation of the FDA’s Emergency Use Authorization Process.

11/ 20/ 2020

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