Your Partner to turn
innovative ideas
into approved products
Navigating the Complexities of
Drug Development
Get expert consulting services to help you streamline your drug development
process and bring new treatments to market quickly and efficiently
What does PharWise Consulting offer?
In 3 Simple Steps
Consulting Services
include:
Formulation Development
Developing a stable and effective formulation for your API can be a complex task
Track record in the formulation development of a variety of APIs, including those that are challenging to stabilize or solubilize.
Focus on Phase appropriate development, regulatory compliance and robustness
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Process Development
Specializing in solving the complex challenges of process development and scale up
Extensive experience in scaling up production from the pilot phase, through cGMP clinical trial manufacturing, and into commercialization.
Using Quality by Design (QbD) principles to de risk the scale up process and ensure that your product meets both quality and regulatory standards
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CDMO Management
CDMO search and management services are designed to ensure that your clinical trials and production run smoothly.
Strong experience in identifying the appropriate CDMOs for your specific needs, large network both in drug substance and drug product manufacturers.
Technical consulting along with project management support for selection and management of outsourcing partners for drug substances and drug products.
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Regulatory CMC
A hands on approach to regulatory submissions, including authoring of CMC regulatory documents and support in regulatory meetings.
Track record of timely regulatory submissions, successful FDA interactions, and NDA approvals.
Comprehensive understanding of CMC development from preclinical to post approval stages, including development of QbD packages, pharmaceutical development reports and control strategies.
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Development Strategy
Clear development strategy helps address the unique challenges of drug development, from scientific, regulatory, and quality perspectives.
Comprehensive analysis of the scientific and regulatory landscape, to help you achieve an effective and efficient development plan.
With a focus on strategic planning, risk management, and proactive decision making, our development strategy services can help you navigate the complex drug development landscape and achieve success in bringing your product to market.
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Quality By Design
The FDA now encourages and looks for QbD components in regulatory submissions.
We can help you not only understand and implement QbD , but also accelerate speed to market, launching valuable, safe, and effective drug products in a reliable and cost efficient manner.
Bring your products to market with a scientifically sound and regulatory compliant approach, through our Quality by Design (QbD) platform.
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Turning innovative ideas into
approved products.
Email Contact – contact@pharwise.com
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