Innovation is our passion. We understand the challenges of modern product development and thrive on the opportunity to provide customers creative solutions based on experience, market insight and cutting-edge science. We focus our development activities on four critical areas necessary for successful topical products: safety, efficacy, patient/consumer compliance and packaging solutions. Within our integrated approach to development, we evaluate every aspect of your new product. Turning ingredients into customized, cosmetically elegant vehicles optimized for drug delivery is our specialty. Our goal is to always deliver a product that meets your performance criteria, timeline and budget.
Our chemists have decades of experience working with NDAs and ANDAs. This includes clinical development and formulation work, as well as scale up expertise.
Our most valued asset is our team: industry specialists whose combined expertise encompasses all aspects of pharmaceutical development and operations. The experience profile of our scientists range from 15-35 years with over 250 ANDA approvals, hundreds of successful formulations of NCEs developed and cGMP Clinical Trial materials.
Our clients depend on WSG Laboratories for many of their cosmetic and OTC needs. Every product we deliver is formulated, tested, and manufactured under the most stringent cGMP conditions. Our ability to deliver on-time products of unyielding quality at competitive prices, with the most advanced ingredients available: this is our unique selling proposition.
Our state of the art Quality Control Laboratories provide significant testing capabilities that include:
We utilize top third party, independent laboratory specialists which enables us to ensure quality of results.
We provide cGMP manufacturing from 10 L to 7,500 L batch sizes with the flexibility to process aqueous, anhydrous and emulsion-based formulations across a wide viscosity range and under an assortment of conditions.
From raw materials to finished products, the analytical lab ensures all aspects of production quality are on target and the specifications for each product are met.
All of our goods and services are available for export, and our team of experts will assist you with the necessary paperwork and documentation to help you expand your business around the world
We operate and partner with various state-of-the-art topical liquid facilities. We have an array of dedicated and segregated batching suites, filling lines, clean rooms, and kitting bays, all operating under controlled conditions. Our facilities are fully zoned to ensure that people, air and material flows cannot cross-contaminate products.
Our regulatory group is experienced in providing assistance to large, mid-sized and start-up pharmaceutical and skincare companies.
We can provide assistance in compiling and submitting Abbreviated New Drug Applications (ANDAs); compiling the Chemistry, Manufacturing and Controls (CMC) information for new and investigational regulatory filings (NDAs and INDs); and assessing OTC and Cosmetic Labeling for compliance to applicable regulations. Our Regulatory group works with our Quality Department to not only ensure regulatory compliance, but to also facilitate a rapid and successful outcome during cGMP inspections.
Our goal, as a turnkey operator, is to accelerate the product approval process through a commitment to regulatory compliance. This has resulted in a successful track record with regulatory filings and approvals for our customers.
We make bringing your products into our many partnership facilities a seamless and smooth procedure. We work hard, in a smart and efficient manner to help you realize the maximum value when outsourcing. Our dedicated Technical Services group is strategically positioned as the interface between Research and Development and Manufacturing Operations. The goal of this group is to ensure a seamless transfer of internally or externally developed products into our manufacturing facility. By incorporating Design of Experiment (DOE) methodologies, Quality by Design (QbD) principles and Risk Assessment strategies, typical transfer challenges are managed proactively and the result is a high confidence level in the robustness of the manufacturing process. The responsibilities of the Technical Services group include the following: