APC Instytut is the leader in the group of companies, which provide complex services for the Polish pharmaceutical market: Rx, OTC and Medical Devices. Since 1996, APC Instytut has been co-operating with national and international pharmaceutical companies. APC provides professional consulting services in the following areas: Regulatory affairs (medicines, medical devices, food supplements, cosmetics); Marketing management; Outsourcing of medical representatives; Recruitment and training.

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Digital Media System Co., Ltd (DMS) provides and supports docuBridge to focus on Japanese market. Address: Tsukiji No.3 Nagaoka Bldg. 2-4-2 Tsukiji Chuo-ku, Tokyo 104-0045, Japan.

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MK Consulting works in the areas of Pharmaceutical Training and Regulatory Affairs Consultancy in Turkey. Regarding Pharmaceutical Training Activities, MK organizes seminars, workshops and conferences about Patents, Pharmaceutical Technology, National and International Pharmaceutical Regulations, Formulation Development, cGMP, Stability etc. Regarding Regulatory Affairs Consultancy, MK provides support to their clients in all kinds of registration related processes of Pharmaceuticals, OTCs, Medical Devices, Cosmetics and Food Supplements such as preparation of dossiers, submissions, national pharmaceutical registration procedures, pricing & reimbursement and other registration related services to both national and international clients. MK Consulting is also the distributor of LORENZ software solutions in Turkey.

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Pharmspot provides access to the unique and innovative service enabling preparation, management and submission of eCTD regulatory affairs dossiers, without the necessity of software implementation and costly investments in technological infrastructure. The concept of subscription access to the system arose as a response to the pharmaceutical and consulting companies needs. Pharmspot incorporates an effective team of software programmers and IT managers who are professionals with long-standing experiences both in Document Management Systems and hardware. The comprehensive services comprise of: Lorenz docuBridge client access based on the subscription system, efficient tool for preparation, management and reformatting marketing authorization of medicinal products dossiers in EU and national procedures, access to the validator of the prepared documents and eCTD submission tool, as well as training and complete technical support for the entire service. Moreover, we cooperate with competent experts on regulatory operation management providing the substantial service of regulatory affairs consulting.

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RES-PONS offers technical expertise in Document Management and Submission Management solutions.

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SOLABS offers an integrated software solution which helps improve Quality operations and processes, and provides critical compliance to 21 CFR Part 11 and other regulatory requirements. The SOLABS solution has proven to be easy to use, operate and maintain.

SOLABS has been a market leader in North-America by deploying best in class Quality solutions exclusively to the Life Sciences market for more than 10 years. SOLABS delivers a complete solution including software, services and support in a simple, cost-effective manner. For more information on SOLABS, contact Ericka Moore (info@solabs.com) or 1-877-322-1368 ext. 219.

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