GMP-Support: Qualification / Validation / Consulting

GMP-Support: Qualification / Validation / Consulting
Product Description

Quasaar does not see itself as "processing office" of service contracts.

As an outsourcing partner, Quasaar also focuses on problem solving, increasing efficiency and process optimization, including on-site consulting and project management.
Our expertise includes i.a. following topics:

GMP aspects in quality assurance and management

Qualification and validation concepts (QC and production)

Software validation

Analytical troubleshooting

Evaluation of QC metadata, resulting formulation improvements

Audit preparation

Qualification and auditing of suppliers

Implementation of innovative techniques in the regulated environment, including process analysis, risk analysis and creation of a qualification or validation concept.

Examination and preparation of GMP-relevant documents

Advice on handling narcotics

GMP support


Quasaar GmbH

  • DE
  • 2017
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
Contract Service

Quasaar GmbH

  • DE
  • 2017
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
Contract Service

More Products from Quasaar GmbH (5)

  • Stability and Ageing Studies

    Product Stability and Ageing Studies

    The Quasaar Stability Centre offers flexible and large-volume storage facilities, which also allow the storage of voluminous packaging units (pallets) up to bulk goods. In addition to conducting ICH studies, it is also possible to place ageing studies, e.g. of medical devices. In this context, leakage and ...
  • Analytical services

    Product Analytical services

    Analytical services 

    In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:

     

    GMP for excipients, risk assessment...
  • Quality Control: Excipients / API / Finished Products

    Product Quality Control: Excipients / API / Finished Products

    Quality Control: Excipients / API / Finished Products
    The service profile of Quasaar GmbH primarily includes the quality control of pharmaceuticals (human and veterinary), active ingredients, raw materials and excipients.

    Hereby the effectiveness and safety of the product for the prote...
  • Stability/Ageing Studies

    Product Stability/Ageing Studies

    Stability/Ageing Studies: 500 m3 to 2000 m3 ICH-Climates 
    The Quasaar Stability Centre offers flexible and large-volume storage facilities, which also allow the storage of voluminous packaging units (pallets) up to bulk goods.

    In addition to conducting ICH studies, it is also pos...
  • Technology Transfer

    Product Technology Transfer

    Technology Transfer
    Methods transfer, risk analysis and robustness investigations, 
    seamless transfer from development stages into the regulated GMP environmentseamless transfer from development stages into the regulated GMP environment

Frequently Viewed Together

  • Product Validation

    Our team of experts will prepare necessary protocols incorporating all critical parameters


    Process Validation:

    PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...
  • Product Quality Compliance

    For Life Science businesses in highly regulated environments, compliance is not an option. Prepare to successfully pass inspections and design post-inspections remediation plans to achieve and maintain approval for your product with PQE Group's tailored and cost-effective programs for Quality Management.
  • Product Hi-End Resource On Demand Solutions

    Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....
  • Product Consulting: Quality Management System

    Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...
  • Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
  • Product IT/EU REGULATORY AFFAIRS - Support and management of RA practices

    OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
    Our expertise ranges from submission of registrations, variations, prices, texts, renewals (also via CESP), to CEP and...
  • Product Clinical Supply

    Recipharm have more than 20 years experience supplying clinical trial material to our clients. Our development facilities cater for a range of clinical trials from preclincal to smaller Phase III trials. We also offer commercial manufacturing for very large clinical batches.
  • Product GPX Porosity

    Material porosity is a relevant parameter in many production process with dry compounds. Actual porosity measurement technologies are using destructive methods. Several disadvantages are connected with the determination of the porosity. The pharmaceutical production of tablets uses the porosity measurement...
  • Product Visual Rotating Inspection Machines

    Inspection machines engineered to operate at high speeds on automatic production and packaging lines, designed to inspect a wide range of glass or plastic containers for liquids (such as solutions, suspensions, emulsions and oil-based products), powders or lyophilized products.
    Our technologi...
  • Product ANDA and NDA Technical Support

    As part of its commitment to full service support, Avéma Contract Services is pleased to offer our customers support with ANDA and NDA applications, including bio equivalency studies, collecting background data, supervising technology tranfers and reviewing applications to make sure that companies com...
  • Product Reference Materials Management Services

    To support you in bringing even safer medicines to the market, we go far beyond supplying you with the right reference standards. From impurity profiling and working standards outsourcing services, all the way to managing inventory and logistics of your reference standards, we're fully equipped to provide ...
  • Product Qualicaps® Inhalation-grade capsules portfolio

    With nearly +125 years of capsule manufacturing experience, and the introduction of several capsule innovations to the pharmaceutical market, specifically in the field of inhaled drug delivery, Qualicaps® offers a broad portfolio of capsules specially designed for inhaled drug delivery, with superior a...
  • Product Aizon Execute

    Intelligent Batch Recording: go fully digital in just 6 weeks
    - Automated recipe conversion
    - Implementation & validation without the heavy lifting
    - Easy workflow management
    - Intuitive GMP environment (easy change management)
    - GxP by design: we are pharma-only
    - Process data unlock...
  • Product Trial filling

    Injection solutions, inhalation solutions, infusion solutions, eye drops and gels, topical agents, oral agents, rinsing solutions, or contact lens cleaning agents – whatever it is you want us to fill, we will conduct trial filling to make sure your products always end up in the best possible containers.
  • Product Klinea Pharmaceutical Engineering

    KLINEA is a company fully committed to providing added value solutions for the life sciences industry, specialized in Engineering Services, Project Management and Quality Scrutineering Tests, with offices in Madrid and Barcelona. Founded by a highly qualified technical team with more than 15 years of e...
  • Product UTPVision LAT 313 ACCREDIA

    The UTPVision LAT 313 is a calibration centre accredited by ACCREDIA and it's able to issue calibration certificates with the guarantee of metrological traceability to the International System of Units.
    Discover more: https://utpvision.com/it/certificazioni-accredia/
  • Product Wasdell QP Services

    Our dedicated QP Services team are able to provide compliance support, audit services, regulatory consultancy and QP certification for imported medicinal products.
  • Product Biologic drug substance CDMO services

    From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
  • Product Automated Leak Testing for Sterile Pharmaceuticals

    Our automated CCI testers for vials, syringes, ampoules, blow-fill-seal containers, IV bags and other pharmaceutical packaging use the latest generation of differential pressure testing or headspace analysis procedures allowing a highly sensitive and robust measurement.

    Highlights: • Indus...
  • Product PeP11 LabCal Excel Platform

    PeP11 LabCal offers a Single Validation SaaS Solution Platform that manages all Excel spreadsheets, eliminating the need for individual validations. This comprehensive electronic Excel solution features an Electronic Signature, Audit Trail, and Role-Based Access, rendering paper signatures unnecessary ...
  • Product Quality Management Services

    Midas Pharma offers wide range of pharmaceutical services which includes quality management services.
    It provides support and services to ensure high product quality and compliance with current valid guidelines and regulations for products used in the pharmaceutical industry - such as APIs, ...
  • Product Biocatalyst production

    Is the enzyme you are interested in not commercially available and a production needs to be developed? Enzymicals has extensive expertise with scale-up from lab to pilot-scale and technology transfers to industrial manufacturing sites. We can supply your protein by in-house production up to the kg-scale...
  • Product Drug Development Consulting

    Our Drug Development Consultants work with you to design and implement successful drug development programs. With industry leading scientific expertise across a range of technical disciplines, we help customers across all stages of development, from candidate selection to commercial launch.

    Our cons...
  • Product Value-added generic development

    Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products.
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  • Product The Competence circle of Biazzi

    BIAZZI supplies a complete know-how and engineering package as well as the related process equipment. BIAZZI offers tests in its test centre to upscale processes and make the basis for the design of the industrial plant. Biazzi is offering the delivery of the Key-Equipment/Basic Engineering or full SKID mo...
  • Product COMPLIANCE

    AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities; 
    TESTING:- Performs the following testing activities using its own instrumentation saving costs and time on tests planning; 
    COMP...
  • Product Scale up simulation and optimization

    We provide scale up and optimization strategy. Scale up is based on experimental small scale data (by Designed experiments) and fed into our simulation system.We use physics and chemistry based modeling in our simulations (no black boxing).
    Get the digital twin of your process!
    Results are clear cont...
  • Product Precious Metal Recovery from Pharma Reactions

    Catalyst characterisation based on an extensive knowledge base and experience, will determine a tailored treatment process, which will deliver the best value returns. Understanding your process where the catalyst is utilised will help determine the treatment route and matrix effects, such as the residual ...
  • Product Biotherapeutics

    To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.

    Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, ...
  • Product Regulatory, CMC and MA sourcing

    We provide regulatory and PV services, which can be tailored to suit individual client needs.
    Our regulatory support includes Marketing Authorisation sourcing, MA transfer, ongoing licencing support, CMC authoring and preparation of type I and type II variations and submission to EMA and national he...
  • Product Validation of AI and non-AI technologies for Life Science companies

    We specialize in AI and non-AI Computer System Validation, equipment validation, utility qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, ANVISA, and other key Life Science authorities across Europe and the Americas. We are a ...
  • Product Analytical services

    Our expertise spans across several critical areas:

     Microbiology analysis  • Microbial Identification (Micro ID) • Bioburden Testing • Endotoxin Testing Utilities Testing (Microbiology and Chemistry) • Water System Testing • Clean Steam Testing • Air Quality Monitoring Raw Ma...
  • Product HEUFT InLine - Empty Containers Inspection

    Covering everything:  a continuous inspection of pharmaceutical primary packaging.

    An all-around inspection of pharmaceutical containers such as jars, vials, flacons or bottles before the filling process – the HEUFT InLine solves this task using a minimum amount of space whilst providin...
  • Product PATVIS APA

    Process Analytical Technology Visual Inspection System for Automated Particle Analysis. Sensum PATVIS APA is process analytical technology visualization system for monitoring, understanding and optimization of fluid bed pharmaceutical production processes. It enables real-time monitoring and fully automat...
  • Product Panoramica prodotti per la produzione farmaceutica / Product overview fo...

    Cambio di formato monitorato con gli indicatori di posizione elettronici SIKO a regolazione manuale diventa al 100 % sicuro nel processo e intuitivo per l'utente

    Rilevamento assoluto della posizione di viti o unità di spinta lineari Interfacce di comunicazione moderne Sensori robus...
  • Product Counting station (reconciliation, position detection)

    Machine learning based flexible tool that can: • count, • detect shapes, • detect mix-ups, • reconciliate. We can adjust our algorithm for very specific needs that your production struggles with. The most universal use is to count samples like vials, syringes, blisters. Other business cases include mult...
  • Product FDA Compliance Monitor (Quality Assurance Tool)

    Automate your supply chain management.  The FDA Compliance Monitor allows you to easily identify vulnerabilities in your supply chain.   You can monitor the status of your own or your suppliers' FDA registration numbers as well as monitor for recalls, inspection results, warning letters, imp...
  • Product Inspection and Packaging Systems

    X-Ray Inspection SystemCapsule Checkweigher
    Metal Detector
    Fuji Flow Wrap
  • Product Method Development, Validation and Transfer

    Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes method development, validation and transfer. Kymos has comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary method...
  • Product HELOS | RODOS & Co. | Particle sizer for Powders, Granules, Suspensions,...

    The proven HELOS series offers a powerful technology for particle size distribution analysis of powders, granules, suspensions, emulsions, sprays and numerous other particulate systems. A size range from below 0.1 µm to 8,750 µm is mastered. The modular system design together with a gre...
  • Product Canister

     2 cups /3 cups  different sterilazation.
  • Product Smart_Color_Premium Pharma

    Fast Industrial Spectrophotometer for Quality Control of transparent Glass and Plastic items: Smart_Color_Premium Pharma allows automatic, objective, easy and fast Color differences of a wide range of transparent Glass and Plastic items.

    Easy and FastSmart_Color_Premium Pharma is the advanced an...
  • Product Mini data logger– testo 174

    The testo 174 mini data logger measures and logs the air temperature and relative humidity in storage rooms and offices continuously without interruption accurately and reliably.

    ·         Display of current temperature/ humidity value
    ·...
  • Product Virtuosi VR powered by QxP

    Virtuosi powered by QxP is the world's first and only comprehensive multi-language immersive training platform for pharmaceutical manufacturing operators in aseptic processing, microbiology, and cell and gene therapy processing. The platform combines in-depth teaching videos with highly immersive virtual r...
  • Product Compliance Management

    PharmSol does not limit itself only to offering Audits, but we expand our solution offerings to ensure complete Compliance at the client's site. Towards obtaining GMP Certification from Europe, United States or WHO, PharmSol has a very effective, systematic and rational approach in providing solutions effi...
  • Product T-Process

    Designed for high temperature processing environments, T-FIT Process caters for a wide variety of process areas demanding heat intolerant insulation that include steam lines, food processing and chemical applications. Remaining stable at operating temperatures up to 160C and up to 200C for steam flushing, ...
  • Product Technical Services

    Complementing development sciences and clinical manufacturing, technical services include consultation on equipment specifications, scale-up, quality control, validation, and compliance auditing. On-site training is available in the fundamentals of lyophilization and validation.

      &nb...
  • Product Method Development and Validation

    GBA Gesellschaft für Bioanalytik mbH provides wide range of pharmaceutical analysis services which includes Method Development and Validation. The development and validation of a new method often seems to be hard and complex. Prior to the start, a lot of facts have to be considered. Beneath the availabilit...
  • Product GMP Auditing

    Intertek design audit and action plans to meet the requirements of pharmaceutical clients to ensure compliance with EC standards, FDA regulations and WHO concerns. During a pharmaceutical audit process, Intertek takes a "snapshot" of the company's existing quality system, and superimposes it on the referen...