Company profile

Aphex Pharma Solutions

Pharmaceutical Quality, CMC and CMC Regulatory Services

Industry
Pharmaceutical Manufacturing
Employees
10
Headquarters
Melbourne, Victoria
Founded
2023
LinkedIn followers
1,872
Office locations
1

Aphex Pharma Solutions company summary

Aphex Pharma Solutions is a company in the Pharmaceutical Manufacturing industry, headquartered in Melbourne, Victoria, founded in 2023. On LinkedIn the company has around 10 employees and 1,872 followers. Its listed specialties include Vendor audits, Mock FDA/TGA/EMA audits, FDA Warning Letter (WL) remediation, Risk Management, CMC Advisory.

What technology does Aphex Pharma Solutions use?

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About Aphex Pharma Solutions

Welcome to Aphex Pharma Solutions, where our team of highly experienced consultants is dedicated to providing top-notch Pharmaceutical Quality, CMC, and CMC Regulatory services. With over 30 years of experience, we have the knowledge and expertise to help our clients succeed in today's competitive pharmaceutical industry. Our team's cross-functional experience in quality assurance, GxP auditing, Chemistry Manufacturing and Control (CMC), and CMC Regulatory is unparalleled. We have worked in TGA/APVMA, FDA/CVM, MHRA/VMD, and EMA regulated environments, giving us a comprehensive understanding of the regulatory requirements and guidelines governing the pharmaceutical industry. Our experience extends across drug substance and drug product manufacturing, including injectable, semisolid, liquid, and solid dosage forms. Contact us if you need help in the following areas; CMC MANAGEMENT • CMC project management • CMC Advisory • Drug substance development • Drug product development • Technology transfer • Stability management • CTD Compilation for New Drug Application • IMPD/IND compilation • Scientific advice meeting assistance QUALITY MANAGEMENT • Vendor audits • Mock FDA/TGA/EMA audits • Internal audits: • FDA Warning Letter (WL) remediation • Risk Management Aphex Pharma Solutions is proud host of Pharmaceutical Development Conference which is held annually in Australia. Inaugurated in 2024, PDC attracts delegates from pharmaceutical research and biotech organisations across Australia and overseas. PDC has presentation tracks in formulation, manufacturing, pre-clinical and clinical development. PDC has become the most scientific conference in pharmaceutical development sector and brings together the entire pharmaceutical development ecosystem in Australia. visit the website using the link below and go to PDC tab for more information. Aphex Pharma Solutions is also the authorised seller of cloudtheapp eQMS.

Specialties

Vendor auditsMock FDA/TGA/EMA auditsFDA Warning Letter (WL) remediationRisk ManagementCMC AdvisoryDrug substance advisoryDrug product advisoryStability planning and program managementCMC project managementIMPD compilationIND compilationCTD compilationScientific advice meeting support

Where is Aphex Pharma Solutions located?

Aphex Pharma Solutions lists 1 location.

Melbourne, Victoria, AUHQ

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Frequently asked questions about Aphex Pharma Solutions

What does Aphex Pharma Solutions do?

Welcome to Aphex Pharma Solutions, where our team of highly experienced consultants is dedicated to providing top-notch Pharmaceutical Quality, CMC, and CMC Regulatory services. With over 30 years of experience, we have the knowledge and expertise to help our clients succeed in today's competitive pharmaceutical industry. Our team's cross-functional experience in quality assurance, GxP auditing, Chemistry Manufacturing and Control (CMC), and CMC Regulatory is unparalleled. We have worked in TGA/APVMA, FDA/CVM, MHRA/VMD, and EMA regulated environments, giving us a comprehensive understanding of the regulatory requirements and guidelines governing the pharmaceutical industry. Our experience extends across drug substance and drug product manufacturing, including injectable, semisolid, liquid, and solid dosage forms. Contact us if you need help in the following areas; CMC MANAGEMENT • CMC project management • CMC Advisory • Drug substance development • Drug product development • Technology transfer • Stability management • CTD Compilation for New Drug Application • IMPD/IND compilation • Scientific advice meeting assistance QUALITY MANAGEMENT • Vendor audits • Mock FDA/TGA/EMA audits • Internal audits: • FDA Warning Letter (WL) remediation • Risk Management Aphex Pharma Solutions is proud host of Pharmaceutical Development Conference which is held annually in Australia. Inaugurated in 2024, PDC attracts delegates from pharmaceutical research and biotech organisations across Australia and overseas. PDC has presentation tracks in formulation, manufacturing, pre-clinical and clinical development. PDC has become the most scientific conference in pharmaceutical development sector and brings together the entire pharmaceutical development ecosystem in Australia. visit the website using the link below and go to PDC tab for more information. Aphex Pharma Solutions is also the authorised seller of cloudtheapp eQMS.

How many employees does Aphex Pharma Solutions have?

Aphex Pharma Solutions has around 10 employees on LinkedIn.

Where is Aphex Pharma Solutions headquartered?

Aphex Pharma Solutions is headquartered in Melbourne, Victoria.

When was Aphex Pharma Solutions founded?

Aphex Pharma Solutions was founded in 2023.

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