Chemical Manufacture and Control (CMC)

This comprises module 3 of the Common Technical Dossier (CTD) covering the quality aspects of the Drug Substance (DS) and Medicinal Product (MP). In this aspect the following services are provided: Reviewing and assessment of Module 3 of the dossier ensuring compliance with the requirements of the relevant Directives and guidelines. Revision of different dosage forms including sterile and modified release preparations among many others. Following are examples of specialised topics carried out and services provided:

Colecalciferol (Vitamin D3) Authorisation in UK & EU

Over the past two years a significant number of applications of different kind- National and DCP of various preparations of Vitamin D3 whether as national or via DCP procedure have been made. The reason for this sudden interest in Vitamin D3 supplement indicated to the requirement to treat Vitamin D deficiency seen in UK, EU and the Middle East. The founder of this consultancy firm holds a very deep experience with the technical details concerning the quality and standard of this important Vitamin

Drug Master File (DMF) Review

The DMF constitutes a vital part of any application that requires close control on the quality of the DS manufactured. In first instance the DMF can only be submitted linked with an application for marketing authorisation of a medicinal product. Following are the services provided: Review and assessment of the contents of the DMF to ensure compliance with current requirements. Work closely with the applicant and DMF holder to provide response to the points of concern raised during the assessment of the application.

Life cycle maintenance, Gap Analysis & Variation applications

During the life cycle of the medicinal product a number of changes may occur which affect its quality, safety and efficacy with direct impact on the requirements and terms laid down by the marketing authorisation (MA) under which the marketing of a medicinal product is authorised in the EU. The variation regulation (EC No 1234/2008) which governs the procedures for the amendment of the decision granting the marketing authorisation and of the technical dossier needs to be satisfied; should the marketing authorisation of the medicinal product is maintained.

Marketing Authorisation in MENA Region

For companies that wish to authorise their products into this lucrative market with a big potential of demand for generics especially those that are manufactured in UK/EU, this consultancy firm is in excellent position to assist in achieving this goal. In taking the advantage of the experience previously gained in the regional pharmaceutical industry and build-up of a good relationship with regulatory authorities and marketing companies including wholesalers, possibly facilitated by the language the following services can be provided:

National & EU procedures preparations and submission

Marketing authorisation of medicinal products in UK and EU are governed by Directive 2001/83/EC as amended. Reference to the relevant Article under which the application is submitted is vital and should be clearly made. As an expert in this filed the following services are provided: Drawing regulatory affair strategy and planning for marketing authorisation of medicinal products. These may be licensed via different regulatory procedures directly affecting the content and the way the dossier is constructed.

Over The Counter (OTC) products

This is a very special field with great diversity. It combines the requirements for licensed medicines with additional provision regarding the population targeted having a direct impact on the size of the market covered and the way it is sold to the public. To add to the complications different authorities in EU may have different regulatory requirements not necessarily unified to become a difficult task to achieve. Having worked for MHRA for more than seven years dealing with this kind of products as an additional responsibility, the following services are provided:

Review of dossier for Marketing Authorisation & Licensing in UK/EU

For marketing authorisation of a medicinal product in EU, the presentation and format of the dossier (CTD) in its five modules (M1, M2, M3, M4 & M5) needs to comply with the current requirements of the EU Directives and guidelines Notice to Applicant Vol 2B. These requirements are of such regulatory and technical details that would need a deep knowledge and experience in revision and assessment of the standard of the dossier.

Scientific Advice

In many cases it is recommended that the applicant would seek the advice of the competent authorities on issues that are of special interest not clearly explained or covered by the current guidelines. The response of the competent authority to the scientific advice sought is important in affecting the dossier preparation and route of submission of the application. Following are the services provided: To review and discuss the project with the applicant with recommendation made.

Specialists in Bioequivalence Studies and Biowaiver applications

This is an important subject that may well decide the outcome of the application for marketing authorisation of medicinal product submitted whether as a generic to the brand in compliance with requirements of Article 10(1) of the Directive or applying for biowaiver in compliance with requirements of Article 10(3) or Article 10(a) of the directive. Different requirements for modified release than for immediate release or gastro-resistant dosage forms are usually imposed.

Technology Transfer

In the process of acquiring the license for marketing authorisation of a medicinal product held by a third party, the acquiring company would need to sign among many a technology transfer agreement/protocol covering areas that are of special interest and importance. Among those are the legal status of the proposed medicinal product, its technical details and how they can be transferred to the new holder. In this aspect the following services can be provided: