Company description

QUASAAR: Efficiency + Innovation = Quality
Quasaar is your experienced and reliable partner for all aspects of product development, quality control, stability studies, analytical services, GMP-support and product optimization and product rescue.
Our competences are focused on the highly regulated pharmaceutical and life science area (GMP). But healthcare, consumer care and food sectors also benefit from Quasaar's own service profile. A high level of experience in the regulated and technical environment as well as a comprehensive competence network (Industry Campus Überherrn, Instillo Group) guarantee high quality and constant innovation.
We accompany you through the lifecycle of your product and support you with analytical services, clinical trials, market launch and long-term marketing of your product.
On the Instillo Industrial Campus in Überherrn we offer 5.000 sqm of ultramodern state-of-the-art laboratories, an innovative and large-volume stability center and a unique development area. There we will initially provide an inspiring and efficient work environment for up to 50 highly qualified employees.
Through a tailor-made outsourcing concept, we are establishing ourselves as a top partner in the pharmaceutical and lifescience industry. We rely on long-term cooperation with our customers in order to successfully position their products on the market. Only the combination of motivated, competent employees, state-of-the-art equipment and new technologies makes this possible. Therefore, the most important goal is the sustained establishment and expansion of a highly qualified employee base. Our mission is to create a work environment characterized by a high degree of innovation and social strength. Together with our scientific partners and partner companies, we create structures and processes for the economic implementation of our activities. This allows the latest technologies to be tested and applied in a practical manner. In cooperation with our excellence partners, we also invest in process optimization and lean management. After all, quality is made possible only by efficient processes and innovative methods.

The goal of our outsourcing concept is the establishment of a stable cooperation based on partnership. Besides the qualitative requirements and adherence to delivery dates, Quasaar focuses on efficient processes and innovative techniques. This guarantees a constant improvement potential of the established methods and procedures as well as cost optimization.
We attach great importance to modern outsourcing management. Quasaar offers a concept tailored to every customer situation that makes superior technologies as fast as possible available for the regulated environment. We use the concept of "lean management" to establish our work processes. The process and result documentation is carried out successively in paperless form. This individually tailored service also integrates a customer-oriented price strategy, based on differentiated hourly rates. The flexibility of a medium-sized start-up, the quality know-how, over 15 years of GMP experience at an international level and an open communication culture create a good perspective on cost minimization and reduction of operating expenses.

The operational fields of Quasaar are:

Quality Control: Excipients / API / Finished Products
Analytics and QC to the highest level – applied to finished pharmaceuticals, medicinal products, ingredients and excipients
Stability/Ageing Studies: 500 m3 to 2000 m3 ICH-Climates
Stability studies and climate storage projects in large variety
Technology Transfer
Methods transfer, risk analysis and robustness investigations,
seamless transfer from development stages into the regulated GMP environment
Optimization / Validation / Transfer of analytical Methods
Many cutting edge – methods including when dealing with all kind of particulate systems
GMP-Support: Qualification / Validation / Consulting
GMP-consulting and training aligned to your daily work.
Product Rescue: Re-formulation & Optimization
Optimization and reformulation of critical formulations based on QC-meta-data or development data (in cooperation with partners at Industry Campus Überherrn)

Set-up and processes follow latest insights in „Lean Management“

Quasaar is your partner in the analysis of sophisticated molecules, analytes and dosage forms with state-of-the-art technologies; In addition to the classic "small molecules" and "solids", we also include:
·       Special dosage forms (eg implants, TTS, mucoadhesive formulations, stents, depot drugs, nano- and micro-suspensions, etc.)
·       Small biologics and molecules that play a role in all types of biotechnological processes
·       Devices with our experience in the establishment and qualification of technologies
·       But also raw materials and auxiliaries where high-quality and reproducible analytics are required.
We offer scalable and efficient solutions for our customers:
·       Seamless transfer of customer methods and technologies to our laboratories and back
·       Large and flexibly expandable stability storage for all requirements (eg large volume parentaralia, veterinary drugs, raw materials (bags, drums, IBCs, medical products, etc.))
·       Rapid provision of analysis capacities according to customer needs, on-site presence and training of the employees at the customer, technical logistics and lab space
·       Our GMP-certified QA system ensures the seamless integration of all documents, results and raw data into the GMP systems of our customers.

Product optimization and product rescue
We generate a specific "added value" from our in-depth understanding and know-how for product optimization and improvement up to product rescue.
For this purpose, we perform meta-analyzes of the available quality data or generate the required data with specific study designs.
Including the formulation experts (MJR-PharmJet) at Campus Überherrrn, we offer conventional or special, especially particulate systems, approaches to compensate product problems. (For details see “Our Expertise”).

Benefits Quasaar
·         State-of-the-art analytical techniques
·         Scalable and modern Quality Control Laboratory
·         Stability & ageing studies in all storage volumes
·         Attractive pricing model
·         Certified cooperation / all processes under cGMP
·         Proven deep GMP–expertise
·         Pragmatism and high efficiency in regulatory issues plus the opportunity for conceptual advice
·         Efficient and proven GMP-system
·         Expertise in all types of formulations including special dosage forms & challenging formulations
·         Highly qualified & GMP-experienced Lab-team
·         Fast track from GMP to R&D
·         Industry Campus provides further competencies and seamless cooperation to partner companies
·         Trusted relationships to authorities and customers
·         Long-standing experience with outsourcing, consulting & pro-active project management

Quick facts

Sales markets Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America
Primary business activity Service
Affiliated categories: Development & Validation of Analytical Methods |Drug Formulation (general category) |Quality Control Testing More

Quasaar GmbH

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