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Pharmakal Limited

Pharmakal Ltd is an independent UK regulatory affairs consultancy established to provide professional assistance to pharmaceutical companies requiring regulatory affairs expertise. Pharmakal Ltd specialises in European regulatory activities and provides advice and assistance to pharmaceutical companies in the areas of product development, marketing authorisation applications, approvals, and licence maintenance. Site designed by Waterside Designs.

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Pharmakal Limited | pharmakal.co.uk Reviews

https://pharmakal.co.uk

Pharmakal Ltd is an independent UK regulatory affairs consultancy established to provide professional assistance to pharmaceutical companies requiring regulatory affairs expertise. Pharmakal Ltd specialises in European regulatory activities and provides advice and assistance to pharmaceutical companies in the areas of product development, marketing authorisation applications, approvals, and licence maintenance. Site designed by Waterside Designs.

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pharmakal.co.uk pharmakal.co.uk
1

Pharmakal Limited

http://pharmakal.co.uk/expertise.htm

In order to obtain timely approvals your applications need to be complete, accurate, presented in the correct format and understandable to the assessor. Pharmakal can ensure your dossier is of high quality and meets these exacting requirements. The range of formulations covered includes tablets, capsules, powders for reconstitution, liquids, creams, gels, foams, sprays and injectables. Site designed by Waterside Designs.

2

Pharmakal Limited

http://pharmakal.co.uk/services.htm

Pharmakal Ltd offers the following services:. 8226; Preparation and submission of marketing authorisation applications. 8226; MA maintenance - Preparation and submission of renewals and variations (Type IA, IB and Type II). 8226; Preparation of Drug Master Files. 8226; Preparation of Summary of Product Characteristics, leaflets and labels. 8226; Dossier evaluation for regulatory compliance. 8226; Regulatory and technical review. 8226; Advice on licensing strategy. Site designed by Waterside Designs.

3

Pharmakal Limited

http://pharmakal.co.uk/index.html

Pharmakal Ltd is an independent UK regulatory affairs consultancy established to provide professional assistance to pharmaceutical companies requiring regulatory affairs expertise. Pharmakal Ltd specialises in European regulatory activities and provides advice and assistance to pharmaceutical companies in the areas of product development, marketing authorisation applications, approvals, and licence maintenance. Site designed by Waterside Designs.

4

Pharmakal Limited

http://pharmakal.co.uk/links.htm

This page contains some links that you may find useful or interesting. We cannot guarantee the links will work all the time and have no control over the availability of these pages. TOPRA (The Organisation for Professionals in Regulatory Affairs). Provides information and training for the regulatory affairs professional. EMEA (The European Agency for the Evaluation of Medicinal Products). Co-ordinates and supports the European licensing system. IMB (Irish Medicines Board).

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