Pharmaconsulta is an independent consultancy firm based in Malta (EU) specialising in pharmaceutical regulatory affairs.

We are a team of highly skilled and motivated individuals who are committed to supporting concerned entities within the pharmaceutical industry by providing cost effective, efficient and holistic regulatory solutions.

Pharmaconsulta Services

We specialise in pharmaceutical regulatory affairs. We pride ourselves in providing the best available service across a vast range of services including:

01. EU GMP

GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals, including vaccines.

GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.

We can assist you in becoming GMP certified by creating and maintaining a quality system, provision of QP services, preparation of site for inspection and training of staff.

02. GDP

Good Distribution Practice (GDP) is concerned with all aspects of the proper distribution of medicinal products for human use. GDP is part of GMP, which focuses specifically on the purchase, receiving, storage and export of drugs intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end-user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

We can provide you with a Responsible Person (RP) to handle all or part of your GDP requirements. We specialise in the creation and implementation of quality systems including the creation of Standard Operating Procedures, quarantine, temperature mapping and pest control. We also provide staff training and inspection readiness to ensure a steady supply chain and the highest client satisfaction.

03. Qualified Person: QP

Holders of manufacturing authorisations must have the services of a Qualified Person at their disposal at all times. The QP is responsible for ensuring that each batch of medicinal products has been manufactured and checked in compliance with Good Manufacturing Standards and in accordance with the requirements of the marketing authorization (Directive 2001/83/EC).

A QP is also needed to ensure that each production batch has undergone a full qualitative and quantitative analysis, in the importing Member State in the case of medicinal products coming from third countries.

We offer contract QP services for manufacturing authorisations as well as batch release. Our highly experienced team of qualified persons operate in line with strict EUcGMP guidelines and are available 24 hours, 7 days a week.

Career Opportunities

Careers

Accounts Executive

An Accounts Executive career opportunity has arisen within Meditpharma Ltd. The selected candidate will report to the Managing…
Careers

Pharmacist

A Pharmacist career opportunity within Meditpharma Ltd. The selected candidate will report to the Managing Director and his…
Careers

Desk/Front Office Clerk

A Drive/Front Office Clerk career opportunity has arisen within Meditpharma Ltd. The selected candidate will report to…
Careers

Sales Executive

Sales Executive career opportunity within Meditpharma Ltd. The selected candidate will report to the Managing Director and…