FDA 2018 Bioanalytical Method Validation - A Practical Assessment
On the anniversary of the 2018 FDA Bioanalytical Method Validation Guidance publication, we assess the implications it's brought to the industry.
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Quinta Analytica
Poskytujeme farmaceutické služby špičkové úrovně po více než dvacet let.
Quality In Time
Since 1997 QUINTA-ANALYTICA has been providing clients a full suite of top-class services and support. The dedication continues today as we offer a complete line of analytical solutions across all stages of the drug life cycle, helping to get products to the market in a fast and reliable way.
Marina Johnson
CEO Founder of unAgency
Marina jns
O nás
Services
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01. APIs Sourcing
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02. Formulation
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03. Pharmaceutical Testing
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04. Clinical Testing
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Nabízíme komplexní řešení od začátku do konce.
QUINTA-ANALYTICA’s five pillars of business and operations provide a complete end-to-end solution.
Navštivte sekci Další služby, kde naleznete další informace a jak vám můžeme pomoci.
Všechny služby
Pharma Testing
Method development & validation
Batch release
In-vitro equivalence
Testing of inhalers
EU QP services
Stability studies
Clinical Studies
Early Phase PK/PD
Medical writing
Recruitment of volunteers
Regulatory science
Statistical data evaluation
Quality assurance
Bioanalytics
State of the art lab
250+ in-house validated methods
Labeled standards
Biostatistics
Preclinical PK & toxicokinetics
Testing of small & large molecules
Pharma Testing
Method development & validation
Batch release
In-vitro equivalence
Testing of inhalers
EU QP services
Stability studies
Clinical Studies
Early Phase PK/PD
Medical writing
Recruitment of volunteers
Regulatory science
Statistical data evaluation
Quality assurance
Bioanalytics
State of the art lab
250+ in-house validated methods
Labeled standards
Biostatistics
Preclinical PK & toxicokinetics
Testing of small & large molecules
Certifikace SVP, SLP, SKP
Inspekce FDA
Společnost QUINTA-ANALYTICA je pravidelně inspektována SÚKLem a již úspěšně absolvovala 10 inspekcí US FDA.
Perfect Template for Agencies
We provide marketing services to startups and small businesses to looking for a partner of their digital media, design & dev, lead generation.
Certifications
10
Team Member
99%
Positive Feedback
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Sleepless Hours
clinic
Our Clinical Labratory
Our in-house Clinical Unit has been operating since 2006, with over 170 BA/BE/PK studies completed.
We provide evaluation of statistical data, report writing, import/export, regulatory submissions, and quality assurance in English, Czech and Russian.
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Clinic
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!
Zdravotnické služby poskytované zkušenými lekáři a sestrami pracujícími v klinické farmakologii, onkologii a interní medicíně.
Schopnost
Klinika nabízí 60 lůžek mající možnost provádět paralelně studie s roční kapacitou 40 klinických studií
Lidé
V naší databázi je více než 16 000 zdravých dobrovolníků.
Laboratoř
Bioanalýzy jsou prováděny ve vlastních laboratořích pracujících v režimu SLP a SKP.
Kompetence
Obtížná manipulace se vzorkem a komplexní lékové formy, včetně injekčních podání.
Dodržování
Jsme běžně kontrolováni SÚKLem a US FDA, bez negativních zjištění.
Vybavení
Jsme registrováni jako nestátní zdravotnická organizace, která funguje v souladu se správnou klinickou praxí.
Partnerství
QUINTA-ANALYTICA je hrdým partnerem IQVIA (dříve Quintiles).
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Contact
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quinta@quinta.cz
+420 242 454 311
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