Doruk Sistem Company Profile

DorukSistem ‘Your Chemical Compliance Partner at Turkey’ Please contact for our «Only Representative» services , SDS Authoring, Translating, Compiling and management solutions and other all related Chemical Compliance topics

www.doruksistem.com.tr

Doruk Chemical Management Systems Limited. Co. has been established in 2005 to guide and lead to the chemical manufacturers, exporters and importers for the compliance with European Union, Global and Local legislations and regulations.

Our Expertise Our regulatory expertise includes regulatory consultants and scientists who have extensive experience dealing with Turkey, EU, and global issues and regulations.

We assist chemical manufacturers, cosmetics manufacturers, pesticide registrants, grower/commodity groups, and trade associations in dealing with issues that affect their ability to do business effectively.

Our regulatory consultants and scientists provide strategic advice concerning regulatory compliance .

«Big Picture»

Doruk Sistem’s consultants work with clients to consider the “Big Picture” by assessing and integrating the regulatory, technical, strategic, and business aspects of each issue on local and global levels.

Using this integrated approach, our consultants advise clients on issues such as product registration, due diligence, registrability assessments, product development, product stewardship strategies, experimental use permits, and reduced risk submissions.

Doruk Sistem consultants have been involved in the preparation of vulnerability analyses, including the evaluation of regulatory, quality control, and business systems, and the development of standard operating procedures, global regulatory models, and compliance manuals and programs.

OUR CAPABILITIES •

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Doruk Sistem’s Center for Chemical Regulation and Occupational Safety specializes in timely, high-quality, creative, and practical solutions to problems that affect our clients' ability to conduct business local and globally.

Our experienced staff includes both technical and regulatory consultants who are experienced in dealing with with pesticide and non-pesticide products, including conventional chemicals, biochemicals, agrichemicals, microbials, antimicrobials, consumer products, and products of biotechnology.

We draw upon expertise in a variety of backgrounds, including epidemiology, biostatistics, toxicology, ecotoxicology, environmental sciences, and risk modeling, to best meet our clients’ needs.

Our international team and partners of regulatory and scientific experts offers additional support for agrichemicals and biocides regulated under Turkey, EU and US directives. Whatever your needs, Doruk Sistem can augment your regulatory team and provide flexible, strategic consulting.

OUR SERVICES «Chemical Management Systems»

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Monitoring & Following Documentation and Licensing Notification and Registration Consulting and Advisory Compilation

Monitoring International regulatory changes Turkish Chemical Regulations, Export and Import testing and analysis, procedures follow-ups, Turkish Standards Institution’s Certifications, etc. Compliance of Turkish Chemical Inventory & Control Regulation Biocidal Products, Plant Production Products, Veterinary Products, Cleaning Chemicals etc., Regulations and import permissions & licensing services Following up of the industrial legislations and import documentation and certification etc. Following up & warning services on the industrial legislations, General consultancy on Turkish and International chemical regulations Marketing and Authorization Applications for Regulatory Affairs

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Consulting and Advisory Registration Technical Services Trainings

The assistance we can provide includes but is not limited to: –Regulatory strategy and advice –Programme and project management –SIEF and consortia management – SIEF Formation Facilitator services and full SIEF/consortium management or participation –Data evaluation and gap analysis – determination of availability of data held by a company and in the public domain and evaluation of their suitability (Klimisch rating), review of data within the SIEF, literature searches and identification of data gaps –Use of Intelligent Testing Strategies (ITS) – identification of data gaps, consideration of grouping and read across, exposure and technical data waivers, expert statements and QSAR modelling –Study placement and monitoring –Dossier preparation and submission – complete dossier in IUCLID 5 including robust and end point study summaries, enquiry dossiers, testing proposals, classification and labelling and toxicokinetics assessment –Chemical safety assessments/reports – identification of uses and exposure routes, hazard assessment, DNEL/PNEC derivation, PBT/vPvB assessment, exposure assessment and development of exposure scenarios, risk characterisation and recommendations on risk management measures –Evaluation and authorisation services – post submission, support, negotiation with ECHA, applications for authorisation and socio-economic analysis –Only Representative and Third Party Representative services

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Environmental Risk Management Green Chemicals Management Carbon footprint Eco friendly final products Enviromental Regulatory Compliance

Environmental Risk Management Identifying and Understanding Environmental Risks and Liabilities is a must especially for Chemical Companies. Understanding these makes it possible to safeguard against and manage these risks and liabilities.

The Doruk Sistem Environmental Risk Management service encompass determining prevailing current and estimating futures Environmental Risks and Liabilities and recommending a strategy for managing these risks.

Energy Efficiency Services Doruk Sistem provides solutions for developing organisation wide energy efficiency programs to: • Decrease the corporate carbon footprint, • Conserve energy, • Measuring energy efficiency performance.

Furthermore, Doruk Sistem supports in implementing actual energy efficiency measures with proper tools for monitoring performances.

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Responsible Person Technical Dossier Preperation Safety Assestment Consultancy Bespoke formulation

We offer the following services to our corporate clients: •Safety Assessment / Toxicology Report •Product Information File assessment and creation •Fragrance Allergen declaration •EU and TR Labelling and packaging compliance •Consultancy in all areas of EU and TR cosmetic laws •GMP Consultancy and Audit •Bespoke Product Formulation and Manufacturing •Responsible Person Services •Notification Services Current clients include both SME and major manufacturers and suppliers from within and outside the EU.

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Certification Consultancy Risk Management Auditing Evaluation Inspection

We offer the following consulting and asvisory services to our corporate clients: •Quality Management System (ISO 9001:2008) •Environmental Management System (ISO 14001:2009) •Occupational Health and Safety Management System (OHSAS 18001) •Risk Management Profiling and Policy Development •Quality Assurance •Chemical Safety Management •Auditing •Inspection •Advisory

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We offer the following consulting and advisory services to our corporate clients: •Workplace Risk Assessments •Corporate Health and Safety Audit •Health and Safety Support Service – Navigator •Task and Staff Risk Assessments •Regulatory advice •Industrial Hygiene We can also liaise with enforcing authorities, bespoke solutions for your business comprising: • • • • •

Initial health and safety consultant’s diagnostic visit Comprehensive documentation and handbooks Implementation and training Further visits to review compliance Regular support and advice

Risk Assestment Auditing Evaluation Regulatory Advice

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Safety Data Sheet Extended SDS , Exposure Scenerio SDS Software CLP Compilation Label Validation

MsdsMarket is leader in delivering high quality, chemical regulatory compliance Safety Data Sheets (MSDS) authoring, compilation and technical translations.

We are committed to providing our clients with first rate services, regardless of the regulatory challenge.

MSDSMARKET Authoring/Writing Service assists companies in Authoring/creating, auditing, writing and updating MSDS, SDS, extended SDS, Exposure Scenerio, CLP Classification Our Technical expert staff has created more than thousands of SDS sheets for both internal purposes and as consultants to our customers.

Please visit our web page now.

www.msdsmarket.com

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Some of our traing topics are as follows: •EU and TR Chemical Regulatory Compliance •EU REACH Regulation •Cosmetics Regulations (SA and SE management) •GMP and GLP •Chemical Safety Assestment •Biocidal Products Regulations •Waste Management •Work Place Health and Safety •DG Goods Transportation and Classification •Hazardous Chemicals Classification •Safety Data Sheet (Expert Courses) •CLP/GHS Classifications •SDS Software trainings •Chemical Risk Management •More and more in Doruk Sistem Academy

Seminars Webinars Courses Workshops Inhouse trainings

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Pharmaceuticals Chemicals Agrochemicals Biocides Medical Devices Cosmetics Food REACH    

SVHC, ROHS, WEEE POHS and more

DIN EN ISO / IEC 17025 Technical Competence, Biocompatibility tests and Microbiological tests for Medical Devices GMP Safety, Conformity with Specifications, Microbiological tests and Bioassays in vitro / in vivo for pharmaceuticals / biologics GLP Traceability, Toxicology, Pharmacology in vitro / in vivo, Pharmacocinetics, ADME, Analytics, Microbiological tests and Bioassays in vitro / in vivo for pharmaceuticals / biologics FDA Our Partner Laboratory was inspected by the US Food and Drug Administration successfully in July 2006 and 2011.

We support customers in protecting the health and safety of man and the environment.

Our customers are industrial enterprises that represent the chemical, pharmaceutical, automotive, electronics, manufacturing and retail industries, to name but a few.

Our solutions include software, process expertise, implementation services, regulatory content and managed services.

ADVANTAGES OF COLLABORATION WITH DORUKSISTEM

 Communication channels with Turkish Ministries and Municipalities.  Follow up of Turkish and EU regulations about chemical industry and environment relations.  Follow up updated technologies about chemical compliance and environmental services.  Networking with industry associations to forecast their needs.  Better understanding of global expertise, served in local philosophy.

Doruk Sistem works with

TSE certificated experts to author and compile legal Safety Data Sheets

Doruk Sistem is an

ISO 9001:2008 awarded Company

Our Partners and Collaborations Organisatons,Universities

Middle East Technical University

Ministry Of Environment and Forestry Of TURKEY

And more ‌

SOME OF OUR INTERNATIONAL CLIENTs

And more …

www.doruksistem.com.tr

Visit us now at www.doruksistem.com.tr

‘Your partner in Turkey’ Please contact for our «Only Representative» services , SDS Authoring, Translating, Compiling and managemnent solutions and other related topics you search for.. info@doruksistem.com.tr