Sasoon

Quality expertise across the life sciences value chain

About Us

We are a life sciences consulting firm, based in the Greater Boston area, serving the pharmaceutical, biotech, and medical device industries globally. We are professional consultants with decades of industry experience in GxP quality, regulatory compliance, clinical development, and business development across the entire value chain.

We serve as an extension of your team while providing a wide array of services to ensure that your organization has the appropriate strategy, infrastructure, and support in place to navigate the complex quality and regulatory framework laid out by regulators globally.

Why work with us?

Experience

Experience

We bring decades of experience across all stages of drug development with projects in the Americas, Europe, and in Asia.

Expertise

Expertise

Our team offers acombination of educational and empirical experience to not only support your quality team needs, but also your organization’s product development regulatory and commercialization timelines.

Excellence

Excellence

Our team strives to provide outstanding service and highquality experience across all service types regardless of the scope and length of engagement.

Services

Quality Management Systems

GxP process and SOP development
Electronic Quality Management System implementation
GxP training program implementation

Quality Unit Augmentation

We support you in fulfilling the regulatory requirement to implement and establish a Quality Unit. We provide seasoned industry experts from the head of quality level to implement and oversee the quality strategy, to quality associates and specialists supporting day to day operations. We function as YOUR highly skilled Quality Unit and offer a variety of customizable solutions to obtain the quality support you need.

Quality and Regulatory Compliance

GxP Audits
- Non-clinical and GLP audits
- GVP audits
- GCP audits
- Internal audits
- GMP audits
Inspections
- Regulatory inspection preparation
- Regulatory inspection response
Regulatory compliance remediation
Gap assessments
Data Integrity assessments

Business Development

Due Diligence
Asset evaluation

QualiCheck

QualiCheck is our propriety and highly customizable program intended to provide an idea of the overall health and phase appropriateness of your Quality System and the state of GxP compliance within your organization. Our experts provide their assessment along with recommendations for improvements and optimizations.

Contact us today for your QualiCheck!

Our Team

Sophia Sassoon

Sophia Sassoon is a seasoned professional with over 20 years of experience in product development, quality, and GxP compliance. Sophia has held a variety of roles with progressively increasing responsibility in QA and QC organizations ranging from big pharma to biotech start ups in stealth mode. Over the past decade, Sophia has helped a multitude of startups establish and scale up their phase appropriate Quality infrastructure to support all phases of development from pre-IND/CTA to commercial post-approval Quality operations. Sophia has extensive experience with successful outcomes during regulatory inspections, including but not limited to the FDA, EMA, and MHRA. Sophia is a pharmacist by training and has a master’s degree in Pharmacy Administration from the University of the Sciences, Philadelphia.

Nathan Sassoon

Nathan Sassoon has over 20 years of experience in pharmaceutical R&D, academic research and teaching, translational oncology research, clinical development, and business development. Prior to consulting, Nathan has worked as a formulation scientist in the area of oral solid dosage forms (small molecules, NCE), a cancer researcher in the area of experimental pharmacology and translational research on NIH and CPRIT funded projects, and a clinical research professional supporting drug discovery, product development, clinical trial monitoring, and business development across a variety of indications in the drugs and biologics space in the US and Europe. Over the past decade, Nathan has provided scientific and strategic direction to angel investors and venture capital on financial analysis, transaction structuring, and scientific due diligence in support of partnerships, mergers, acquisitions, product licensing, and business development initiatives within the life sciences sector. Nathan is a pharmacist by training, has a master’s degree in pharmaceutics, and a PhD in pharmaceutical sciences from Texas Tech University Health Sciences Center, Amarillo.

Contact Us×

info@sassooncs.com