Valentia Analytical – Analytical Lab Born in GMP

ISO/IEC17025:2017 Accredited
FDA Registered
GMP Compliant

Valentia Analytical provides fast and high quality analytics for products in research and development or early to late clinical stages. Our CGMP compliant analytical testing lab relies on strong technical expertise to develop robust methods for quality testing. We work hard to ensure reliable and accurate analytical testing services. Our facility houses a beautiful workspace, the strong systems bring structure, state of the start technology delivers robust data, relations bridge communication, and core values drive execution.  We will work with you to unravel the story.

ISO/IEC17025:2017 Accredited
FDA Registered
GMP Compliant

Upon the first year

ANALYTICAL

QUALITY

WHAT WE DO

Valentia Analytical is a CGMP compliant analytical testing lab, here to provide fast and high quality analytics for products in research and development or early to late clinical stages.  Our technical expertise is applied into developing robust methods to do quality testing.

We are so passionate about what we do that we also teach it.

Analytical Testing Laboratory

Valentia Analytical has positioned itself as a reliable partner for companies looking to create safe and CGMP compliant products and get them on the market fast. We have developed an expertise in various industries, where we provide analytical, quality control and quality systems solutions.

 

We support product development through all preclinical and clinical phases

Whether it is biological, pharmaceutical, gene therapeutic or medical devices, Valentia Analytical is committed to upholding the highest standards of quality. 

Who is Valentia Analytical?

Valentia Analytical is an analytical laboratory local to the Northern Bay Area of California. Committed to upholding cGMP standards, our mission is about returning data fast with utmost quality. The faster we deliver… the faster your new drugs and products can help patients around the world.

Valentia’s analytical laboratory is supported by strong foundations of expertise, quality and reliability. We strive to not only be compliant to all requirements and regulations, but to be a model of efficient analytical testing in America. Quality by Design is deeply embedded in our own laboratory and quality systems so we can better support you.

Our facility provides a beautiful workspace, systems bring structure, state of the art technology delivers robust data, relations bridge communication, and core values drive execution.

Our Contract Analytical Laboratory Services

Valentia Analytical offers a wide range of analytical testing services that supports your progress throughout all phases of drug discovery and drug development. From preclinical to clinical trials and market launch, Valentia works closely with your company to ensure an airtight quality control of your new compounds and devices.  We are connected with other laboratories to provide a holistic CMC package and bring the data together.  

Our analytical testing & characterization cover Proteins, Small Molecules, Drug-device Combinational Products and Drug-Biologic-Device Combinational products.

Analytical Methods Development and Validation, ICH Q2

Our in-depth knowledge and expertise ensure the development and validation of appropriate methods for your different products, at every stage of development. We specialize in:

  • Methods Development
  • Methods Validation

cGMP Raw Material & Cell Media

  • Amino Acid Analysis
  • Water Soluble Vitamins
  • Identification, Purity, Content

Capillary Electrophoresis

  • CE-SDS
  • Imaged CIEF
  • KeyInstrumentation: Protein Simple Maurice

Stability Programs, ICH Q1

  • -80 °C
  • 2-8 °C
  • 25°C / 60%RH
  • 40°C / 75%RH

Characterization

  • Forced Degradation Studies
  • Sterilization Impact Analysis
  • Product Investigations

Pharmaceopeia / Physico-Chemical Testing

  • Appearance
  • pH
  • pH, low volume
  • UV Spectrophotometry by SoloVPE
  • UV Spectrophotometry by Conventional Spectrophotometer
  • Loss on Drying

Cell-based & Immuno-assays

  • Bioassay
  • ELISA
  • Key Instrumentation: Molecular Device M5e

cGMP Lot Release & Stability

  • Physico-Chemical - appearance, pH
  • Identification
  • Content
  • Purity
  • Potency
  • Impurities - aggregates, related substances
  • Degradation Products
  • Drug Release
  • Dissolution

Ultra-High/High Performance Liquid Chromatography

  • Reversed-Phase
  • Ion-Exchange
  • Size-Exclusion
  • Affinity
  • Hydrophilic Interaction
  • Key Instrumentation - UHPLC with UV, UHPLC with MS

Drug Release and Dissolution

  • USP Dissolution Apparatus
  • Dissolution Sampling Station

Why choose our analytical testing laboratory?

Take advantage of our experience

We find that every product has a story.  Unraveling this story greatly facilitates understanding and communication.  To accomplish this, Valentia Analytical works to bridge data between the various phases of development, applying what has been learned from experience with testing other products. We build upon our specific expertise with a multitude of analytical methodologies and how they have been applied across many different products.

Analytical Services

  • Drug products
  • Biologics 
  • Medical devices 
  • Gene therapy
  • Raw materials testing

QUALITY CONTROL

Our quality control ensures a solid drug development process with qualified methods, such as purity and stability testing of samples, to demonstrate drug product compliance.

  • Purity
  • Potency
  • Impurities
  • Degradation products
  • Drug release
  • Physico-chemical analysis

QUALITY SYSTEMS

Valentia Analytical develops strong quality systems through the development of methods that build quality into your product from the beginning of the development process.

  • Quality Management System
  • GMP compliant
  • Inspection ready

What additional services are offered by Valentia Analytical?

We are passionate about our work and are committed to continuous improvement in the quality of produced drugs and the health and safety of patients everywhere. Valentia Analytical offers a LC Theory and Quality Principles Course to interested individuals. 

Through this class taught by our founder Kenneth Gomez, students and professionals will learn more about fulfillment of CGMP requirements for IND, NDA, or BLA submissions. We encourage the participation of individuals involved with the following analytical testing services:

  • Method Development
  • Method Validation
  • Method Transfer
  • Characterization
  • Quality Control
  • Quality Assurance
  • Data Review
  • Regulatory Filings

CONTACT US

48501 Warm Springs Blvd., Suite 107, Fremont, CA 94539

(510) 280-5886

(510) 280-5887

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