Incorporated in 2010 and based in Malta (EU), Pharmaconsulta is a team of experienced professionals who put together their efforts to provide regulatory and legal consultation to the Pharmaceutical, Food Supplement and allied sectors.
The team which is made up of Pharmacists, Lawyers and Sales and Marketing advisors has worked in the pharmaceutical field for many years.
Pharmaconsulta has already obtained a good number of Licenses, Permits and Notifications enabling penetration and distribution of medicinal as well as non medicinal products within the EU market for the respective Pharmaceutical and Food Supplement industries.
Our services enable EU and non-EU pharmaceutical companies to successfully penetrate the EU market by advising on how to comply with the strict regulartory bodies in European Countries.
Our goal is to support:
Pharmaceutical Suppliers, Manufacturers and Contractors
Active Ingredient and Excipient Manufacturers, Wholesalers/Distributors
Logistics Companies
Contract Laboratories
through their regulatory GxP (Good Distribution / Manufacturing / Laboratory Practice) requirements and offer a smooth transaction throughout.
Pharmaconsulta ensures that all the regulatory matters are met. Wether it is storage or distribution, we are very experienced in setting up quality programmes and distribution processes through Standard Operating Procedures (SOPs) in a way to fullfill the GDP* stringent requirements. We will provide advice on determining the most cost effective and efficient quality system.
We offer the professional services of Contract Responsible Persons (RPs) or the training of your in-house Responsible Person which is a mandatory key role to be in line with EU regulartory standards.
Pharmaconsulta not only takes care of pharmaceutical regulatory matters, but we also handle all legislation, registration and virtual or actual licencing through our in-house legal advisors.
*(Directive 2001/83/EU, Directive 2004/27/EC,EU Guidelines on Good Distribution of Medicinal Products for Human Use 94/C63/03)
Pharmaconsulta offers the following services:
Quality System Development
Creation of Documentation
Standard Operating Procedures (SOPs)
Record Keeping
Contract Responsible Person (RP)
Virtual Contract Responsible Person (vRP)
Obtaining a Wholesale Dealers Licence (WL)
Obtaining a Virtual Wholesale Dealers Licence (vWL)
Good Manufacture Practice (GMP) Audit
Good Distribution Practice (GDP) Audit
Pharmaceutical Supply Chain Advice
The benefits of Obtaining a Virtual Wholesale Dealers License (WL)
A WL is required for the sale and distribution of medicinal products within the EU. Each and every pharmaceutical wholesale dealer requires a license issued from the relevant regulatory body in that European country.
For such a license to be issued he must be compliant with the standards of GDP (Good Distribution Practice). Directive 2003/94/EC .
Malta has been known to have favorable tax benefits. While many companies register their company in Malta to benefit from this favorable tax rate, Pharmaconsulta can make it possible that overseas pharmaceutical wholesale dealers can register their company in Malta and obtain their wholesale dealers license in Malta, via a vWL loophole, to continue or start the distribution of medicinal products in any country within the European Community without having to pay the high tax rates of their originator country.
Contract Responsible Person (RP)
The provision of an RP is a legal requirement for obtaining a Wholesale Dealers License (WL) from any regulatory body such as the MHRA in the UK, MA in Malta, AIFA in Italy and other International Regulatory Authorities including EMEA, and the relationship between the company Directors and the appointed RP is a vital one.
A formal legal contract should be put in place that defines the relationship between the contract RP and your company, and satisfies the regulatory bodies.
The team which is made up of Pharmacists, Lawyers and Sales and Marketing advisors has worked in the pharmaceutical field for many years.
Pharmaconsulta has already obtained a good number of Licenses, Permits and Notifications enabling penetration and distribution of medicinal as well as non medicinal products within the EU market for the respective Pharmaceutical and Food Supplement industries.
Our services enable EU and non-EU pharmaceutical companies to successfully penetrate the EU market by advising on how to comply with the strict regulartory bodies in European Countries.
Our goal is to support:
Pharmaceutical Suppliers, Manufacturers and Contractors
Active Ingredient and Excipient Manufacturers, Wholesalers/Distributors
Logistics Companies
Contract Laboratories
through their regulatory GxP (Good Distribution / Manufacturing / Laboratory Practice) requirements and offer a smooth transaction throughout.
Pharmaconsulta ensures that all the regulatory matters are met. Wether it is storage or distribution, we are very experienced in setting up quality programmes and distribution processes through Standard Operating Procedures (SOPs) in a way to fullfill the GDP* stringent requirements. We will provide advice on determining the most cost effective and efficient quality system.
We offer the professional services of Contract Responsible Persons (RPs) or the training of your in-house Responsible Person which is a mandatory key role to be in line with EU regulartory standards.
Pharmaconsulta not only takes care of pharmaceutical regulatory matters, but we also handle all legislation, registration and virtual or actual licencing through our in-house legal advisors.
*(Directive 2001/83/EU, Directive 2004/27/EC,EU Guidelines on Good Distribution of Medicinal Products for Human Use 94/C63/03)
Pharmaconsulta offers the following services:
Quality System Development
Creation of Documentation
Standard Operating Procedures (SOPs)
Record Keeping
Contract Responsible Person (RP)
Virtual Contract Responsible Person (vRP)
Obtaining a Wholesale Dealers Licence (WL)
Obtaining a Virtual Wholesale Dealers Licence (vWL)
Good Manufacture Practice (GMP) Audit
Good Distribution Practice (GDP) Audit
Pharmaceutical Supply Chain Advice
The benefits of Obtaining a Virtual Wholesale Dealers License (WL)
A WL is required for the sale and distribution of medicinal products within the EU. Each and every pharmaceutical wholesale dealer requires a license issued from the relevant regulatory body in that European country.
For such a license to be issued he must be compliant with the standards of GDP (Good Distribution Practice). Directive 2003/94/EC .
Malta has been known to have favorable tax benefits. While many companies register their company in Malta to benefit from this favorable tax rate, Pharmaconsulta can make it possible that overseas pharmaceutical wholesale dealers can register their company in Malta and obtain their wholesale dealers license in Malta, via a vWL loophole, to continue or start the distribution of medicinal products in any country within the European Community without having to pay the high tax rates of their originator country.
Contract Responsible Person (RP)
The provision of an RP is a legal requirement for obtaining a Wholesale Dealers License (WL) from any regulatory body such as the MHRA in the UK, MA in Malta, AIFA in Italy and other International Regulatory Authorities including EMEA, and the relationship between the company Directors and the appointed RP is a vital one.
A formal legal contract should be put in place that defines the relationship between the contract RP and your company, and satisfies the regulatory bodies.
| Company Name | Pharmaconsulta |
|---|---|
| Business Type | Distributor/Wholesaler, Association, Business Service (Transportation, finance, travel, Ads, etc) |
| Main Products | Regulatory Affairs GMP GDP GLP Regulatory Services, Consultation, Pharmaceuticals, Medicinal products, Food Supplements, Whey protein |
| City | Birkirkara |
| Country/Region | Malta |
| Company Website | http://www.pharmaconsulta.com |
| Contact Person | Mr. Pharma consulta |
| Telephone | 0************2 View all, please login |
| Street Address | TMG SERVICES, Tumas Fenech street |
| Zip Code | BKR2526 |
| sell123 URL | http://www.sell123.org/company/Malta/728448.htm |