Pharmaconsulta

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Pharmaconsulta Pharmaconsulta is Malta's very first and only Pharmaceutical Regulatory Affairs Consultancy Firm.

Advising on regulatory strategies for the most efficient & cost effective ways to comply with today's stringent GMP and GDP regulations. We specialise in obtaining Marketing authorisations, GMP certificates, Batch release, Audits, preparation for inspections and pharmaceutical wholesale dealers licences. We also offer services of Contract Qualified persons, contract responsible persons and laboratory analysts.

Pharmaconsulta is your guide to a smooth EU market launch!We'll help you simplify the process and get your product to pa...
28/05/2024

Pharmaconsulta is your guide to a smooth EU market launch!

We'll help you simplify the process and get your product to patients faster.

Send us a message now.


We want you and your products to be recognized in the EU. Our experts have the experience and knowledge to guide you thr...
23/05/2024

We want you and your products to be recognized in the EU.

Our experts have the experience and knowledge to guide you through every step of the EU approval process.

Inquire now.


Don't worry about the maze of EU Pharma regulations! Pharmaconsulta's regulatory consultants can be your guide, helping ...
21/05/2024

Don't worry about the maze of EU Pharma regulations!

Pharmaconsulta's regulatory consultants can be your guide, helping you navigate the process for a smooth market entry.

You can ask our experts by calling us.


Our comprehensive suite of services and in-depth regulatory guidance ensure a smooth and efficient process for bringing ...
16/05/2024

Our comprehensive suite of services and in-depth regulatory guidance ensure a smooth and efficient process for bringing your pharmaceutical product to market.

Message us now to start!


✅Since EU regulations emphasize quality and safety, you have to ensure your manufacturing processes and product developm...
14/05/2024

✅Since EU regulations emphasize quality and safety, you have to ensure your manufacturing processes and product development adhere to the highest standards.

❎ By taking the time to thoroughly understand and meet EU standards, you'll ensure a smoother process, avoid unnecessary expenses, and ultimately bring your valuable product to European patients faster.

Follow us tips on how to fast track you product's entry to the EU.


Accelerate your journey to market success with our seasoned expertise in navigating the intricate landscape of EU regula...
10/05/2024

Accelerate your journey to market success with our seasoned expertise in navigating the intricate landscape of EU regulations.

Our tailored guidance empowers you to streamline processes, mitigate risks, and seize opportunities, ensuring your products reach consumers efficiently and compliantly.

Let us be your trusted partner in overcoming regulatory hurdles and achieving your business objectives swiftly and confidently.

Follow us for essential updates and tips on market entry.


✅ This centralized approach not only streamlines the regulatory process but also grants widespread marketing approval th...
08/05/2024

✅ This centralized approach not only streamlines the regulatory process but also grants widespread marketing approval throughout the EU member states.

❎ By prioritizing integrity and adhering to stringent quality standards, you not only mitigate regulatory risks but also safeguard the trust and safety of your consumers.

Follow us for essential updates and tips on market entry.


01/05/2024

President Marie-Louise Coleiro Preca met Prof. Giustino Varrassi, president of the Paolo Procacci Foundation (www.fondazioneprocacci.org) and president-elect of the World Institute of Pain (http://wip.agoria.co.uk) at San Anton Palace to discuss the programmes of potential development of pain medici...

01/05/2024

In conclusion, falsified medicines are a growing threat to public health. They can pose serious risks to patients' health and well-being and represent a significant challenge to the pharmaceutical industry. It is essential that pharmaceutical wholesalers and distributors take measures to identify, a...

https://pharmaconsulta.com/eu-market-access/    Our company is composed of specialised pharmacists and medical doctors w...
01/05/2024

https://pharmaconsulta.com/eu-market-access/

Our company is composed of specialised pharmacists and medical doctors who have extensive work experience at EU GMP and GDP approved sites as well as many years in regulatory positions such as Responsible Person (RP) and Qualified Person Pharmacovigilance (QPPV) positions. Our clients include international pharmaceutical companies based both inside and outside of the EU, as well as local distributors that require regulatory and licensing support.

We provide specialist advice and assistance with particular emphasis on EU GMP/GDP/GLP/GACP and GVP guidelines. The services we offer include but are not limited to:
► EU market accession
► Contract Responsible Person (RP), Qualified Person (QP) provision
► EU GMP/GDP/GACP Audits and Licensing
Good Manufacturing Practice (GMP) – Good Distribution Practice (GDP) – Good Agricultural and Collection Practice (GACP) – Medical Cannabis – Quality Management Systems – Standard Operating Procedures (SOPs) creation
►FMD Decommissioning of 2D Bar Codes
►Medical Devices
►Pharmacovigilance
Dossier Submission Review – EUQPPV and LCPPV Services – Post Marketing Life Cycle Management – Medical Cannabis – Quality Management Systems – Standard Operating Procedures (SOPs) creation
►Laboratory Testing
►Contract Manufacturing
►Clinical Trials
►Logisticts Consultation
►Food Supplements and Cosmetics Registration
The firm was set up to provide high quality regulatory assistance to clients involved in manufacture and distribution of medicinal products and other manufacturing processes that require a Quality Management System to be in place.

We offer our expertise and professional know-how to enable both EU and non-EU pharmaceutical companies to successfully access the EU market. Our team of experts will ensure that your company achieves full compliance with the stringent requirements laid down by European Law in order to facilitate EU....

With our comprehensive guidance and support, you'll gain the expertise needed to navigate  EU regulations seamlessly, pa...
29/04/2024

With our comprehensive guidance and support, you'll gain the expertise needed to navigate EU regulations seamlessly, paving the way for sustained growth and prosperity in your pharma company.

Don't be left behind!

Try and experience our expertise.


Understanding EU regulations is the cornerstone of market access and success! Arm yourself with the knowledge necessary ...
25/04/2024

Understanding EU regulations is the cornerstone of market access and success!

Arm yourself with the knowledge necessary to confidently pe*****te the EU market.

With our expertise and resources at your disposal, you'll be equipped to navigate the complexities and emerge victorious in this area.

Try our services now.


At our company, we're all about helping pharma companies like yours break into the market swiftly and confidently. With ...
23/04/2024

At our company, we're all about helping pharma companies like yours break into the market swiftly and confidently.

With our expert guidance and support, you can pass through the regulations and make your mark in no time.

Message us now.


Based on your experience, what are the biggest challenges pharma companies face when entering the EU market? Vote below ...
11/04/2024

Based on your experience, what are the biggest challenges pharma companies face when entering the EU market?

Vote below and share your thoughts in the comments!

We understand these hurdles, and our team of specialists is here to help you overcome them.

Message us to know how!


Pharma Consulta helps pharma companies unlock EU access with ease. Our team of regulatory experts, market access special...
09/04/2024

Pharma Consulta helps pharma companies unlock EU access with ease.

Our team of regulatory experts, market access specialists, and logistics partners will guide you through every step of the process, from navigating complex regulations to finding the right partners and ensuring smooth distribution.

We take the stress out of EU market entry, so you can focus on what matters most: getting your life-saving or life-changing treatments to the patients who need them.

Contact us now to start.


EU regulations got you feeling lost in a maze? Don't let them block your path to the lucrative European market!Our team ...
06/04/2024

EU regulations got you feeling lost in a maze? Don't let them block your path to the lucrative European market!

Our team of pharmaceutical access experts are here to be your guide. Whether you're an EU or non-EU company, we'll help you navigate the complexities and ensure smooth compliance with EU regulations.

Let's unlock full market access for your life-changing pharmaceuticals. Contact us today for a chat about your specific needs.


Our team behind the scenes is passionate about helping pharma companies navigate the EU market. They're not just experts...
04/04/2024

Our team behind the scenes is passionate about helping pharma companies navigate the EU market.

They're not just experts, they're driven individuals who believe in the power of groundbreaking medications reaching patients who need them most.

Let's chat about how their expertise can unlock your EU market potential!



Address


Opening Hours

Monday 09:00 - 17:00
Tuesday 09:00 - 17:00
Wednesday 09:00 - 17:00
Thursday 09:00 - 17:00
Friday 09:00 - 17:00

Telephone

+35679303202

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Our Story

Advising on regulatory strategies for the most efficient & cost effective ways to comply with today's stringent GMP and GDP regulations. We specialise in obtaining Marketing authorisations, GMP certificates, Batch release, Audits, preparation for inspections and pharmaceutical wholesale dealers licences. We also offer services of Contract Qualified persons, contract responsible persons and laboratory analysts.