GXP Consultants, Inc.

Pharmaceutical Services

ANALYTICAL CHEMISTRY

Our robust capabilities support your projects:

Drug substances
Drug products
Various dosage forms

GXP is committed to providing expert and timely analytical chemistry support. We offer high quality, affordable compendial testing according to USP/NF, EP, BP, JP, ACS and customer-specified monographs in support of raw materials, in-process analysis, and finished product release testing. We specialize in handling drug substances, drug products and various dosage forms including tablets, capsules, semi-solids, parenterals and sterile liquids. Our device specialists oversee routine chemical and functional testing of packaging (elastomers, glass, plastics) and component testing. We also assist with vendor and contract manufacturer qualification.

In addition to validation consulting services for device, diagnostics, dietary supplements, drugs, biologics, GXP is unique in providing comprehensive Residual Solvents Testing and Extractable and Leachables Testing for your validation projects.

MICROBIOLOGICAL TESTING FOR VALIDATION

We perform a wide array of tests, including but not limited to:

Rapid screening for mycoplasma
In-vitro cytotoxicity testing (biocompatibility)
Adventitious virus testing

GXP offers extensive testing services via our highly qualified microbiology team. Our depth of expertise combined with our novel approach to attentive project management and high quality reporting ensure the timeliness your projects demand.

Irvine offers a broad range of compliant, expert-lead microbiological services. Tests are performed according to official compendial methods such as USP, EP, BP, JP, AAMI, ISO standards and client specific protocols. Validated Class 1000 clean room suites with Class 100 LAF hoods provide the highest quality sterility testing for finished product release.

In addition to validation consulting services for GMP facilities, equipment, cleaning, test methods and process, GXP is unique in providing comprehensive laboratory validation services for facility environmental monitoring, pharmaceutical water testing, pharmaceutical steam testing, pharmaceutical gases testing, analytical method development and validation, cleaning method development and validation and process method development and validation for your validation projects.

ANALYTICAL DEVELOPMENT

Capable of supporting multiple dosage forms:

Injectables (lyophilized and non-lyophilized)
Inhalation
Respiratory
Solids, semi-solids, liquids
Transdermal

GXP's fully-compliant cGMP laboratories delivers prompt, reliable development and validation results. In fact, we have developed more than 300 methods in support of a wide range of dosage forms. Our scientific depth, innovative approach to seamless project management, and project reports consistently exceed client expectations. In support of pre-clinical, NDA, and ANDA, we start with the application filing date, plan backward to determine fundamental milestones and establish effective timelines to meet your submission date. The process integrates cutting-edge science, embeds quality and safety surveillance, and delivers reliable data submission and post project follow-up.

BIOPHARMACEUTICALS TESTING & PRODUCTION

GXP is capable of a full range of production and testing for small and large biomolecules:

Nucleic acids and oligonucleotides
Peptides
Natural and recombinant proteins
Monoclonal and polyclonal antibodies

From proof of concept to commercialization, GXP offers reliable expertise, quality systems, and state-of-the-art instrumentation from our fully cGMP compliant facilities. What's more, we maintain focus on the leading edge of science, service and seamless collaboration. GXP provides a range of services such as API manufacturing, cell line development, GMP peptide and protein production, and the development of dosage forms. Our responsiveness and streamlined project management can help leverage your supply chain capabilities and improve project efficiencies that can reduce time to market. At GXP our mission is to provide our clients with outsourcing solutions that make their drug development priorities possible.

PREFORMULATION/FORMULATION

GXP is Capable of supporting multiple dosage forms:

Injectables (lyophilized and non-lyophilized)
Inhalation
Dry powder inhalers
Respiratory
Solids, semi-solids, liquids
Transdermal

With close to two decades of experience, we continue to strengthen our depth of service in response to the needs of our customers. Preformulation studies are designed with an anticipated formulation strategy, route of administration, and ultimate formulation configuration in mind. Parameters are generated to aid formulation development and/or support preparation of the CMC sections of your IND, NDA, ANDA, or BLA. Formulation development begins with a thorough understanding of your needs and consideration of the physico-chemical properties of compounds derived from preformulation studies. As development partners, we will design detailed protocols to help select clinical formulations.

GXP mission is to provide you with outsourcing solutions that make your drug development priorities possible.

STABILITY TESTING

We support your projects for:

Clinical trials
BLAs
NDA
IND
ANDA

GXP offers you state of the art cGMP stability storage facilities with walk in and reach in validated environmental chambers set to various temperatures and humidity conditions, all in accordance with ICH guidelines.�Environmental and photostability chambers are monitored 24 hours a day by a computer-based Environmental Monitoring System. Laboratory Information Management System (LIMS) ensures the highest level of compliance and is fully capable of complex trend analysis. The system accommodates sophisticated sample management and allows the Stability Department to generate cumulative reports.

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	Pharmaceutical Services ANALYTICAL CHEMISTRY Our robust capabilities support your projects: Drug substances Drug products Various dosage forms GXP is committed to providing expert and timely analytical chemistry support. We offer high quality, affordable compendial testing according to USP/NF, EP, BP, JP, ACS and customer-specified monographs in support of raw materials, in-process analysis, and finished product release testing. We specialize in handling drug substances, drug products and various dosage forms including tablets, capsules, semi-solids, parenterals and sterile liquids. Our device specialists oversee routine chemical and functional testing of packaging (elastomers, glass, plastics) and component testing. We also assist with vendor and contract manufacturer qualification. In addition to validation consulting services for device, diagnostics, dietary supplements, drugs, biologics, GXP is unique in providing comprehensive Residual Solvents Testing and Extractable and Leachables Testing for your validation projects. MICROBIOLOGICAL TESTING FOR VALIDATION We perform a wide array of tests, including but not limited to: Rapid screening for mycoplasma In-vitro cytotoxicity testing (biocompatibility) Adventitious virus testing GXP offers extensive testing services via our highly qualified microbiology team. Our depth of expertise combined with our novel approach to attentive project management and high quality reporting ensure the timeliness your projects demand. Irvine offers a broad range of compliant, expert-lead microbiological services. Tests are performed according to official compendial methods such as USP, EP, BP, JP, AAMI, ISO standards and client specific protocols. Validated Class 1000 clean room suites with Class 100 LAF hoods provide the highest quality sterility testing for finished product release. In addition to validation consulting services for GMP facilities, equipment, cleaning, test methods and process, GXP is unique in providing comprehensive laboratory validation services for facility environmental monitoring, pharmaceutical water testing, pharmaceutical steam testing, pharmaceutical gases testing, analytical method development and validation, cleaning method development and validation and process method development and validation for your validation projects. ANALYTICAL DEVELOPMENT Capable of supporting multiple dosage forms: Injectables (lyophilized and non-lyophilized) Inhalation Respiratory Solids, semi-solids, liquids Transdermal GXP's fully-compliant cGMP laboratories delivers prompt, reliable development and validation results. In fact, we have developed more than 300 methods in support of a wide range of dosage forms. Our scientific depth, innovative approach to seamless project management, and project reports consistently exceed client expectations. In support of pre-clinical, NDA, and ANDA, we start with the application filing date, plan backward to determine fundamental milestones and establish effective timelines to meet your submission date. The process integrates cutting-edge science, embeds quality and safety surveillance, and delivers reliable data submission and post project follow-up. BIOPHARMACEUTICALS TESTING & PRODUCTION GXP is capable of a full range of production and testing for small and large biomolecules: Nucleic acids and oligonucleotides Peptides Natural and recombinant proteins Monoclonal and polyclonal antibodies From proof of concept to commercialization, GXP offers reliable expertise, quality systems, and state-of-the-art instrumentation from our fully cGMP compliant facilities. What's more, we maintain focus on the leading edge of science, service and seamless collaboration. GXP provides a range of services such as API manufacturing, cell line development, GMP peptide and protein production, and the development of dosage forms. Our responsiveness and streamlined project management can help leverage your supply chain capabilities and improve project efficiencies that can reduce time to market. At GXP our mission is to provide our clients with outsourcing solutions that make their drug development priorities possible. PREFORMULATION/FORMULATION GXP is Capable of supporting multiple dosage forms: Injectables (lyophilized and non-lyophilized) Inhalation Dry powder inhalers Respiratory Solids, semi-solids, liquids Transdermal With close to two decades of experience, we continue to strengthen our depth of service in response to the needs of our customers. Preformulation studies are designed with an anticipated formulation strategy, route of administration, and ultimate formulation configuration in mind. Parameters are generated to aid formulation development and/or support preparation of the CMC sections of your IND, NDA, ANDA, or BLA. Formulation development begins with a thorough understanding of your needs and consideration of the physico-chemical properties of compounds derived from preformulation studies. As development partners, we will design detailed protocols to help select clinical formulations. GXP mission is to provide you with outsourcing solutions that make your drug development priorities possible. STABILITY TESTING We support your projects for: Clinical trials BLAs NDA IND ANDA GXP offers you state of the art cGMP stability storage facilities with walk in and reach in validated environmental chambers set to various temperatures and humidity conditions, all in accordance with ICH guidelines.�Environmental and photostability chambers are monitored 24 hours a day by a computer-based Environmental Monitoring System. Laboratory Information Management System (LIMS) ensures the highest level of compliance and is fully capable of complex trend analysis. The system accommodates sophisticated sample management and allows the Stability Department to generate cumulative reports.	13681 Newport Avenue Suite 8-620 Tustin, CA 92780 (714) 325-8896