Nordic Pharma Group

Indeus Life Sciences

inouit — 2007-11-12T18:24:16Z

INDEUS Life Sciences is a recently-established, Mumbay-based pharmaceutical development laboratory providing complete and high-quality formulation development services in full compliance with international standards and regulations, and in particular with those in the EU and the USA. The company’s services include the following :

Formulation development
Process validation
Analytical method development and validation
Technology transfer services
Stability studies as per ICH guidelines

The experienced management of INDEUS has extensive knowledge in product development for the US and EU markets.

INDEUS Life Sciences
SU Motor's Complex
Balrajeshwar Road
Model Town, Mulund (W),

Mumbai
Maharashtra 400 080, INDIA
Tel. +91-22-4161-1123
Fax. +91-22-2591-6792
Email. indeus@indeus.in

QPharma

inouit — 2007-10-22T10:12:49Z

QPharma was established in 1999 in Malmö, Sweden, and is a Specialised Pharmaceutical Service company in the Nordic Group that is dedicated to pharmaceutical development and speciality contract manufacturing.

QPharma has a philosophy of constantly optimising its efficiency and being a lean, highly competent manufacturing and product development organisation.

Specialist expertise

The QPharma chemists, pharmacists and formulation specialists have extensive know-how in pharmaceutical development, including formulation development, analytical methods, stability studies and pilot plant testing.

This pharmaceutical development and manufacturing know-how is particularly evident in the field of products based on controlled-release technologies and controlled-release vaginal ring technologies. In addition to the development and manufacture of these formulations, QPharma has expertise in liquid and other formulations as well. QPharma can produce restricted drugs, such as oncology products and hormones, in a dedicated production suite within its facilities.

The QPharma packaging division can offer an equally impressive array of services, ranging from small volumes in glass jars to millions of packed blister tablets.

Q for Quality

The Q in QPharma stands for Quality, and all activities are controlled and validated to ensure the best achievable safety and quality. QPharma’s manufacturing site is FDA-approved and compliant with US, EU and other international GMP manufacturing requirements.

Pharmaceutical services

Today, QPharma’s FDA-approved site provides services to an impressive array of large and small International customers, including Swedish, European and US-based companies.

QPharma is ready to take on the challenge of new production and pharmaceutical development programmes in the EU, the US and other international markets.

Please visit our website : www.qpharma.com

QPharma - Sweden
Agneslundsvägen 27
201 25 Malmö
Sweden
Tel. +46 40 36 18 00
Fax. + 46 40 18 28 55
E-mail. info@qpharma.se

Prague Clinical Services

inouit — 2007-10-22T10:12:47Z

Prague Clinical Services has been a specialised pharmaceutical services company in the Nordic Group since 2004. Established in the historical and culturally-renowned city of Prague in the Czech Republic, its customers include a range of third parties interested in using PCS’s specialist services and clinical expertise in the form of partnership arrangements. Prague Clinical Services has developed into one of the leading independent Clinical Services providers in the Czech Republic and in Central & Eastern Europe.

Clinical expertise & Services

PCS’s experienced team provides a complete solution for clinical research projects from phase I to phase IV.

PCS’s services focus on the project management of local & international studies, the identification of investigational sites, including site feasibility & assessment, the drafting of trial-related documents (including protocols and final reports), the management of regulatory & ethical approvals, the organisation of investigators’ meetings and their training, the set up of an administrative database to track patients & investigational sites, the complete management of data and statistical evaluation, in-depth monitoring (including source data verification & drug accountability), the management of investigators’ contracts and payments, and study close-out activities.

In addition to the above, PCS provides services in the field of Quality Assurance & Drug Safety, Data Management & Biostatistics and Medical Writing.

The PCS customer base includes, among others, a number of major international CROs and speciality pharmaceutical companies.

Quality

Meeting the highest EU GCP standards is a prerequisite for the clinical study needs of all of international clients ; therefore, reputable international GCP auditors continuously monitor the clinical studies entrusted to PCS.

Meeting the highest international GCP standards, efficiency, diligence and achieving its clients’ objectives are the key elements behind PCS’s rapidly expanding reputation in the Industry. With a strong expertise base in the Czech Republic, as well as access to large number of potential clinical trial sites in the region, PCS can meet these customer requirements and is well placed to do so in a highly cost efficient manner.

Please visit our website : www.pragclin.com

Prague Clinical Services - Czech Republic
Zachova 8
140 00 Praha 4
Czech Republic
Tel. +420 241 029 551
Fax. + 420 241 442 852
E-mail. info@pragclin.com

Disphar International

inouit — 2007-10-22T10:12:44Z

Disphar International is a well-established and reliable Pharmaceutical Services Company and a respected business partner in the European pharmaceutical industry.

Disphar provides a range of high-quality products and services, which include registration dossiers, Marketing Authorisations and the management of industrial product supply to a wide range of pharmaceutical companies throughout Europe.

Specialised expertise

Disphar’s company philosophy is to maintain a highly efficient, lean and flexible internal organisation that focuses on key competencies and activities.

This concept enables Disphar to secure specialised expertise for any pharmaceutical project, to select the best locations for development projects, and to keep resources, capacity and know-how in line with customer demand. In addition to its teams in the Netherlands, Disphar has established an office in India to strengthen Disphar’s product development focus and to assist with product sourcing and manufacturing activities through collaborations with selected specialised companies.

Pharmaceutical product & services

The company’s broad product portfolio originates from internal pharmaceutical development projects as well as from partnerships with pharmaceutical companies that have chosen to benefit from and capitalise on Disphar’s specific expertise and extensive European customer base. Disphar offers complete business solutions to its multinational clients, including product development, EU Dossier registration, regulatory support, commercialisation and supply arrangements, and full QA/QC support.

Quality

Disphar’s company culture, organisation and strategies all focus on achieving full customer satisfaction by providing products and services of outstanding quality. Disphar’s QA/AC department carefully selects and regularly audits all development and manufacturing partners. Disphar’s development, manufacturing and logistic services comply with the latest EU GMP, GLP and GDP requirements.

Please visit our website : www.disphar.com

Disphar International - The Netherlands
Tolweg 15
3741 LM Baarn
The Netherlands
Phone. +31 35 5280 400
Fax. +31 35 5480 585