About Eagle analytical services
Eagle Analytical Services: Your Trusted Partner for Analytical and Microbiological Testing
Eagle Analytical Services is a leading provider of analytical and microbiological testing services for compounding pharmacies, 503B outsourcing facilities, and CGMP manufacturers. With over 20 years of experience in the industry, Eagle has established itself as a trusted partner for quality control testing, method development, validation, and consulting services.
At Eagle Analytical Services, we understand the importance of accurate and reliable testing in ensuring the safety and efficacy of pharmaceutical products. Our state-of-the-art laboratory facilities are equipped with advanced instrumentation and technology to provide comprehensive analytical solutions tailored to meet your specific needs.
Our team of highly skilled scientists has extensive experience in developing and validating methods for a wide range of pharmaceutical products including sterile injectables, ophthalmics, inhalation products, topical creams/ointments/gels/lotions/solutions/suspensions/emulsions/powders/tablets/capsules/softgels/tinctures/drops/syrups/elixirs/injectables/pellets/beads/microspheres/nanoparticles/liposomes/exosomes/vaccines/biologics/biosimilars. We also offer microbiological testing services to ensure that your products are free from harmful microorganisms such as bacteria/fungi/molds/viruses/mycoplasma/endotoxins/pyrogens.
Our comprehensive range of analytical services includes:
1. Method Development & Validation: We develop robust methods that meet regulatory requirements (USP/NF/BP/EP/FDA/EU) using various techniques such as HPLC/UPLC/GC/LCMS/GCMS/ICPMS/AAS/DSC/TGA/DMA/HPTLC/Capillary Electrophoresis/Microscopy/Spectroscopy etc., depending on the nature of your product.
2. Stability Studies: We conduct stability studies under ICH guidelines (ICH Q1A(R2)) to determine the shelf-life or expiration date of your product under different storage conditions (25°C /60%RH; 30°C /65%RH; 40°C /75%RH).
3. Container Closure Integrity Testing: We perform container closure integrity tests using various techniques such as dye ingress test/helium leak test/vacuum decay test/high voltage leak detection test etc., to ensure that your product is protected from contamination during storage or transportation.
4. Extractable & Leachable Studies: We conduct extractable & leachable studies on packaging materials/components used in manufacturing process to identify potential contaminants that may migrate into your product over time.
5. Elemental Impurities Analysis: We analyze elemental impurities (As/Pb/Hg/Cd/Cr/Ni) present in raw materials/products using ICPMS/AAS technique according to USP <232>/<233> guidelines.
6. Cleaning Validation Studies: We perform cleaning validation studies according to FDA guidance document "Guidance for Industry - Process Validation: General Principles & Practices" using swab/rinse sampling technique followed by HPLC/UPLC analysis or TOC analysis depending on nature/type/formulation/product contact surface area/cleaning agent used etc..
7. Consulting Services: Our team provides expert consulting services related to quality control/testing/regulatory compliance issues faced by our clients across all stages/phases/steps involved in drug development/manufacturing/distribution/marketing/lifecycle management process.
Why Choose Eagle Analytical Services?
1) Quality Assurance - At Eagle Analytical Services we follow strict quality assurance protocols throughout our operations ensuring accuracy/reliability/reproducibility/traceability/integrity/transparency/confidentiality/customer satisfaction at every step/process/procedure/task performed by us.
2) Regulatory Compliance - Our laboratory complies with cGMP/GLP regulations set forth by FDA/EU/Japan/MHRA/TGA etc., which ensures that our clients receive high-quality data/results/reports/documentation required for regulatory submissions/approvals/compliance audits.
3) Experienced Team - Our team consists of highly qualified scientists who have extensive experience working with pharmaceutical companies across all stages/phases/steps involved in drug development/manufacturing/distribution/marketing/lifecycle management process.
4) State-of-the-Art Facilities - Our laboratory is equipped with advanced instrumentation/technology/software systems/data management tools/LIMS/electronic signatures/electronic records/archival systems/back-up systems/disaster recovery plans/security measures/fire suppression system/environmental monitoring system/waste disposal system/etc., which ensures efficient/effective/timely delivery/service/support without any downtime/interruption/errors/failures.
5) Competitive Pricing - At Eagle Analytical Services we offer competitive pricing without compromising on quality/service/support provided by us.
Conclusion
In conclusion,Eagle Analytical Services is committed towards providing high-quality analytical solutions tailored specifically towards meeting the needs of compounding pharmacies ,503B outsourcing facilities ,and CGMP manufacturers .With an experienced team ,state-of-the-art facilities,and strict adherence towards regulatory compliance,Eagle offers unparalleled service at competitive prices .Choose us today,and let us be your trusted partner for all things related towards analytical testing!