When you might need our support?

• New plant building

This is a big investment and you have to be sure that it will be satisfactory on the long-term basis. You might need to re-estimate your business strategy and to reassess your product portfolio from a different point of view: market volume, competition, product life cycle, capacity, technology, profitability etc. Conceptual design will give you general overview how your new plant should look. In order to fulfill all technical, technological, cGMP and regulatory requirements, evaluation study will help in decision about most cost-effective technical solution by carrying out a preliminary process design evaluation, and feasibility study will present a detailed capital and investment analyses. During detail design expert audit, it will be extremely important to avoid mistakes in the stage of execution. Finally you have to choose partner for project execution on turnkey basis or not. In both cases you have to supervise project completion, especially in the case of critical systems (HVAC, Clean rooms, PW, WFI, Clean steam etc.)

• Reconstruction of existing facilities

If you are faced with the need to upgrade or reconstruct your production facility the first step is to define your own requirements and expectations. All problems and weak points (bottlenecks, inefficient areas, quality etc) should be resolved by best usage of your existing resources and cost effectiveness.

• Equipment purchasing

In the case when you purchase new equipment you have to assess process needs and to choose the most appropriate solution. Preparation of good bidding documentation will help you to make good decision in tendering process. All technological, GMP, environmental and regulatory issues should be taken in consideration.

• Development of new business strategy

If you intend to improve or change current approach to the business or to enter new area of pharmaceutical business you will need strong support of knowledge relating to medical science, perspectives in disease management, status of world wide pharmaceutical business, strategies of the leading companies, emerging markets, characteristic of drug market and factors influencing it. The range of studies relating to your main idea has to be performed before you find success in new business.

• Product portfolio improvement

The basic resource of every pharmaceutical company is its product portfolio and the most important condition for permanent growth is good product policy. Product portfolio has to be continuously assessed and accordingly improved.

• Equipment, process or cleaning validation

If you whish to comply with the standards of pharmaceutical regulatory authorities your facility, equipment and processes have to be validated. Starting from the Validation Master Plan preparation design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), cleaning validation and final Validation Review report have to be prepared.

• GMP upgrading

GMP is a culture that has resulted in a revolutionary approach to design and functioning of the pharmaceutical industry. If you have problem in complying with these standards their resolution should be priority in your business development. It is not always need for high investment; sometimes that’s a lack of appropriate documentation or quality system management or operators training. Based on audit, problems can be defined and plan for corrective actions proposed. Documentation preparation and management can be improved by application of knowledge and experience from European Community and United States practice.

• Establishment of new organization

It seems easy to reach good organization and coordination of numerous functions within pharmaceutical company, but a number of problems could be explained with inappropriate organization. Taking in consideration all particular characteristic of one company from one side and current principles of organization from the other, for every particular case the best solution can be implemented. Good organization is key for your high-level customer service and application of new approach to logistic functions (supply chain) or development function (project management) will save you money and keep your business on the right track.

• New product introduction

There is a lot of cases when a technology transfer process has to be performed: introduction of new product from internal development, introduction of acquired or licensed product, start up of new/reconstructed facility, manufacturing site change, contractual production for third party etc. It is crucial to have good, well-coordinated plan of activities and to follow up its realization in order to achieve required productivity and quality and full documentation important for regulatory procedure.

• Resolving production or business problem

Even in very good companies a range of daily problems or functions which could be improved can be found: product formulation, missing documentation, capacity utilization, increased customers claims, etc. It is important to identify the problem and possible solution. Based on alternative case studies it is easy to choose the best and cost effective solution.

• Product outsourcing

Product portfolio upgrading is a continual process and your success in pharmaceutical business depends strongly from the product policy you have. Except your internal development there are other possibilities to introduce new product: acquisition, licensing, co-marketing etc. In order to make good choice you will need in every case deep study relating to general trends in pharmaco-therapy, conditions and future trends on domestic and foreign markets and medical doctrine from one side, and your internal resources and expectation from the other.

• Product registration

The primary prerequisite for your success and growth on domestic and export markets is to have market authorization for products you intend to commercialize, as well as to provide permanent change control procedure for registered products. You will need to prepare appropriate registration dossiers, to accept visit of external auditors or to communicate with regulatory authorities.

• Site Master File and Site Master Planning preparation

Site Master File is not only the main GMP document. It is at the same time ID of your company. If you wish to communicate successfully with customers, regulatory authorities or potential business partners you have to prepare and continuously update your Site Master File and prepare Site Master Planning.

• Representation

If you intend to enter Yugoslavia drug market we can support your business efforts by providing you registration service, as well as a range of studies relating to Yugoslavia drug market: product demand, pricing policy, domestic competition, regulatory requirements etc.

Copyright © 2003 Dren Farma in cooperation with Kennet Bioservices Limited.

Last modified: January 01, 2011