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Welcome to ASE Pharma Solutions website.
We are a professional and dynamic growing company,
providing a wide range of services for pharmaceutical
industry sector.
We always provide the highest quality services.
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Regulatory requirements for medicinal products for human use in the context of the COVID-19 pandemic
- 2 November 2021
The European Commission, EMA and the European medicines regulatory...Read More -
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The use of monoclonal antibodies to treat COVID-19
- 8 February 2021
EMA’s human medicines committee (CHMP) is reviewing available data...Read More -
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Vaccines against COVID-19
- 10 December 2020
Comirnaty (BNT162b2) (BioNTech and Pfizer) Spikevax (mRNA-1273) (Moderna Biotech...Read More -
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How to demonstrate comparability for ATMPs?
- 18 May 2020
CHMP scientific advice questions are often related to...Read More -
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Update On 21 February 2022, the European Commission...Read More -
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Medical Devices Regulation
- 21 April 2020
On 3 April 2020, the European Commission has adopted...Read More -
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Coronavirus disease (COVID-19)
- 3 April 2020
Treatments and vaccines against COVID-19 Update Remdesivir...Read More -
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Metformin diabetes medicines and N-nitrosodimethylamine (NDMA) – a probable human carcinogen
- 7 December 2019
NEW! URGENT! Update EMA and EU...Read More -
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First non-injectable treatment for severe hypoglycaemia!
- 30 October 2019
On 17 October 2019, the Committee for Medicinal Products...Read More -
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Esketamine (Spravato) with the positive CHMP opinion for combination treatment in adults with treatment-resistant major depressive disorder
- 23 October 2019
On 17 October 2019, the Committee for Medicinal Products...Read More -
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Nitrosamines in human medicines – consequences for MAHs
- 7 October 2019
EMA’s human medicines committee (CHMP) is requesting...Read More -
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On 8 March 2019, the European Medicines Agency...Read More -
EMA is to start a review of...Read More -
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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers – implications for QPs
- 29 August 2019
With the recognition by the US Food and Drug...Read More -
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The exemption from EU batch re-testing for imported ATMPs
- 27 August 2019
On 21 August 2019 EMA has published document entitled...Read More -
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The first cannabidiol containing medicinal product with a positive opinion in the EU centralised procedure!
- 22 August 2019
On 25 July 2019, the Committee for Medicinal Products...Read More -
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On 21 February 2019, the European Medicines Agency (EMA)...Read More -
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Use of OOS batches of authorised cell/tissue-based ATMPs – Section 11.5 of the Guidelines on GMP for ATMPs
- 27 June 2019
On 25 June 2019 EMA has published document entitled...Read More -
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Omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack!
- 25 June 2019
On 29 March 2019 EMA confirmed that omega-3 fatty...Read More -
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IMPORTANT! Update Having considered the knowledge...Read More -
EMA’s safety committee (PRAC) has recommended that the marketing...Read More -
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Medicinal products
- 22 May 2019
REGISTERS OF MEDICINAL PRODUCTS MEDICINAL PRODUCTS A...Read More -
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Brexit and EU rules for medicinal products for human use and veterinary medicinal products
- 7 March 2019
DO NOT RELY ON THE TRANSITION PERIOD! The...Read More -
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In view of the considerable uncertainties, in particular concerning...Read More -
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Brexit and EU rules for batch testing of medicinal products
- 27 February 2019
According to Article 51(1)(b) of Directive 2001/83/EC and Article...Read More -
- EMA Authorities in the EU are taking action...Read More
- EMA EU authorities are placing the Chinese company...Read More
- EMA The European Medicines Agency (EMA) is expanding...Read More
- EMA The European Medicines Agency (EMA) has updated...Read More
- EDQM The EDQM is continuing the investigations...Read More
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Revision of the EU GMP Guide – Annex 2
- 27 August 2018
The revised Annex 2: Manufacture of Biological active substances...Read More -
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Revision of the EU GMP Guide – Annex 17 (Part II)
- 23 August 2018
Recently, the European Commission published a revised version of...Read More -
- The company Zhejiang Tianyu is no longer authorised to...Read More
- The European Medicines Agency (EMA) is reviewing medicines containing...Read More
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GMP for Advanced Therapy Medicinal Products (ATMPs) (Part II) and hospital exemption (HE)
- 14 February 2018
On 22 November 2017, the European Commission (EC)...Read More -
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On 14 August 2017, the European Medicines Agency (EMA)...Read More -
On 2 May 2017, the European Commission and EMA...Read More -
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Clinical investigation of medicinal products in the pediatric population – Addendum to ICH E11
- 17 October 2017
On 6 October 2017, the European Medicines Agency (EMA)...Read More -
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(Q)SAR models – important tool of risk assessment to support practical implementation of ICH M7 guideline
- 29 September 2017
A general concept of qualification of impurities (or degradation...Read More -
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On 25 July 2017, the European Medicines Agency (EMA)...Read More -
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Is the risk of GMP dis-harmonisation in the field of ATMPs (Advanced Therapy Medicinal Products) real?
- 12 May 2017
The PIC/S Committee, which comprises representatives of PIC/S’ 49...Read More -
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First-in-human Clinical Trials – FIH CTs (Part I)
- 12 April 2017
Clinical trials are essential for the development of medicines...Read More -
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GMP and MAHs
- 13 October 2016
Update On 29 July 2021, the European Medicines...Read More -
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FDA has published “Quality Metrics Technical Conformance Guide”
- 30 September 2016
Recently, FDA has published a new technical specifications document...Read More -
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GMP for ATMPs (Advanced Therapy Medicinal Products) (Part I)
- 15 September 2016
On 28 June 2016, the European Commission (EC) released...Read More -
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On 29 April 2016, EMA published a new document...Read More - On 13 April 2016, EMA released for 6 months...Read More
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On 19 January 2016, the European Medicines Agency published...Read More -
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Revision of the EU GMP Guide – Annex 16
- 18 October 2015
On 12 October 2015, the European Commission published revised...Read More -
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Revision of the EU GMP Guide – Annex 17 (Part I)
- 14 October 2015
On 15 September 2015, the European Commission released for...Read More -
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On 28 July 2015, FDA published a draft guidance...Read More -
On 9 July 2015, EMA released for 6 months...Read More -
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Revision of the EU GMP Guide – Annex 15
- 12 May 2015
On 30 March 2015, the European Commission published revised...Read More -
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ICH published a Final Concept Paper for a new ICH Q12 Guideline
- 25 February 2015
Recently, ICH published a Final Concept Paper for a...Read More -
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Active substance starting material(s) – importance of selection
- 4 December 2014
According to the Part II: Basic Requirements for Active...Read More -
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Revision of the EU GMP Guide – Chapter 6
- 21 October 2014
On 28 March 2014, the European Commission published revised...Read More -
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Revision of the EU GMP Guide – Chapter 8
- 7 October 2014
On 13 August 2014, the European Commission published revised...Read More -
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Revision of the EU GMP Guide – Chapters 3 and 5
- 4 October 2014
On 13 August 2014, the European Commission published revised...Read More -
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According to an Article 46(f) of Directive 2001/83/EC as amended for...Read More