| 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 thats 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. |