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URRA CMC
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22 February 2024

Drug Quality Surveillance Program

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6 February 2023

ICH Q9 Quality risk management - Scientific guideline

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10 July 2019

Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry

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18 November 2022

Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle

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29 October 2019

Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry

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19 April 2018

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations

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The Latest

Drug Quality Surveillance Program

22 February 2024

Read More

ICH Q9 Quality risk management - Scientific guideline

6 February 2023

Read More

Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry

10 July 2019

Read More

Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle

18 November 2022

Read More

Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry

29 October 2019

Read More

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations

19 April 2018

Read More

Guideline on computerised systems and electronic data in clinical trials

10 March 2023

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Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

31 December 2016

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Providing Over-the-Counter Monograph Submissions in Electronic Format

27 September 2022

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US FDA

Control of Nitrosamine Impurities in Human Drugs

General, Clinical, Procedural, Post-approval

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As Health is the main priority in our lives, it is important that patients get the most appropriate and safe treatments in the fastest and most reliable way without compromising of its quality.

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​Apsyos offers small and medium pharmaceutical and biologic manufacturers the freedom to focus their internal capacities towards Science and Clinical Concerns by alleviating technical regulatory aspects.

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