“Pharmagate” LTD

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Pharmagate® - is a consulting, service and optimum solutions for the industry that produces products:

  • medicines
  • immunobiological products
  • medical devices
  • biologically active substances
  • nutritional supplements and special food
  • products for hygiene
  • medical equipment
  • cosmetics

Consultation in the field of regulatory strategy at different stages of the life cycle of the product with the analysis of local legislation features and the regulatory framework.

We provide a full range of services that help companies to manage every stage of the process - from idea to access the market till approval and launch of products on territories of our region - Russia, Ukraine, Kazakhstan, Belarus, Moldova, the Caucasus - Georgia, Armenia, Azerbaijan, Central Asia - Kyrgyzstan, Turkmenistan , Tajikistan and Uzbekistan and Mongolia.

In Pharmagate we can organize any project for regulatory support of  product for healthcare, regardless of the size and timing. From the submission of applications for approval of the product, to the more complex problems of management of post-approval activities. We are experts in this field and can provide information on the market to meet any regulatory issues in Ukraine, Russia and CIS countries. We are always up to date with current legislation, regulations, industry initiatives and the interpretation of the rules.

Pharmagate understands the vital role of supporting the product after it is approved to ensure its turn and sales, the possibility of its intended use and maintain its position in the market of health care products and provides approval of:

  • variations
  • renewal of registrations
  • the expansion of indications for use
  •  providing an effective system of pharmacovigilance and quality monitoring

We offer:

  • advice regarding the structure of the registration dossier required by law, the essence of documents , the nuances of approval procedure of medical devices;
  • examination of pre-registration dossier;
  • preparation of documents;
  • samples and sample documents, internal guidelines for the preparation and registration dossier;
  • translation of required parts of dossier, legalization of documents;
  • import of samples (if necessary);
  • maintenance of the examination phases, the answers to the questions in cooperation with the holder of the rights for manufacturing;
  • development of the text of labeling in compliance with the law;
  • examination of the draft registration certificates and supporting documents package;

The professional experience, reputation and active attitude of our employees based on long established contacts with the different authorities  allows us to address all issues quickly and efficiently.

Long, positive and fruitful cooperation with medical and healthcare scientific community gives us a lot of opportunities in realizing of different medical/marketing initiatives and research&development programs interesting for your business development and strategical positioning of your products on market.

Pharmagate committed to meet the needs and expectations of our clients by providing professional and superior quality service, with integrity and reliability.

For R&D companies we guarantee strict data confidentiality and full respect of intellectual property rights, as well as full adherence to international Product Information policies and local regulations:

  • Translation from English into Russian of Product Information (Summary of Product Characteristics, International Prescribing Information, Patient Information Leaflet)
  • Back translation
  • Product Information Updates
  • Scientific and clinical summaries for local regulatory submissions
  • Scientific medical consultations/medical information handling/support in promotion & advertising of pharmaceutical products
  • Help in preparation of promotional materials for healthcare professionals
  • Scientific editing of local publications etc.
  • Preparation of analytic reviews on given subject
  • Preparation for product launch
  • Develop and support KOLs and Advisory Board Members to optimise the use of External Professional opinion
  • Preparation of modules for disease and product training
  • Training for medical representatives
  • Educational & medico-social activities for consumers
  • Medical Questions handling (creation of standart questions/answers database, write standard professional, scientifically based responses)

System of Pharmacovigilence

  • Providing training and consulting for company personnel (DRA specialists, safety specialists, medical representatives, CRAs etc.) in Pharmacovigilance, GCP, incl. Safety Reporting terms, and guidelines.
  • Processing of Spontaneous Safety Reporting & Pregnancy cases for marketed products in accordance with local regulatory requirements and company procedures
  • Periodic Safety SUSAR Reports handling

Quality Assurance System

  • Development and monitoring of actual Quality manuals
  • Standard Operating Procedures system creation and update
  • Consulting & evaluation of current QA system
  • Risk points assessments
  • Preparation to GMP/CQA audits

Additional Information

 

MPI Union Members

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Pharma Armenia

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Pharma Magazine

pharma-10

In April 2015 Medicine Producers and Importers Union of Armenia and “GXP” Centre of Excellence published the 10th issue of pharmaceutical scientific magazine “PHARMA”.

 

www.pharma-mag.am


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