From advice to full-spectrum support, we offer comprehensive solutions for pharmaceutical business:
- Registration and submission support in all aspects of regulatory affairs, from accompanying documents to creating dossiers
- Medical and pharmaceutical translation service
- Selection, supply, installation and validation of equipment and technological systems for pharmaceutical industry
- API, excipients and reference standard supply
REGULATORY SUPPORT AND PHARMACOVIGILANCE
We provide all-round support in gaining the CIS pharmaceutical and medical device market.
From advice and guidance to the full-spectrum regulatory support, we focus on the following services:
- Registration Dossier Preparation (in Russian, English and other languages if needed)
- Adaptation of Documentation in Compliance with the local CIS Legislation (Belarus, Kazakhstan, Russian Federation, EAEU)
- Primary and Secondary Packaging Mock-up Preparation
- High Efficiency for Variations, Renewals and Notifications, Answers, Reports etc.
- Organization of Preclinical and Clinical Research.
- Obtaining of Permits and Handling Official Queries and Resolutions
We work with the following product groups:
- Medicinal products
- Medical Devices
- Nutritional Supplements
- Cosmetic Products
GLOBAL SUBMISSIONS
As a part of International Regulatory Group DeltaMed Ajans we provide global submission services.
PHARMACOVIGILANCE SUPPORT
We offer the outsource pre-registration and post-marketing pharmacovigilance service including:
- Assignment of a Qualified Person for Pharmacovigilance;
- Safety Monitoring of Marketed Medicinal Products;
- Literature Screening for Adverse Events Detection;
- Preparation of Periodic Safety Update Reports and other documentation
MARKETING RESEARCH
- Evaluation of the need in the investigated medicinal product on the local pharmaceutical market and its sales potential by conducting sales-dynamics research and analysis for various treatment group product in retail, hospital, and reimbursement segments
MEDICAL TRANSLATION
Translation & Medical Writing - Linguistic Support you can rely on
MEDICAL AND PHARMACEUTICAL TRANSLATION
- We provide exceptional quality medical& pharmaceutical translation due to implemented quality assurance procedure
- All our translators are qualified to an MSc, Ph.D. or MD level and have a proven language proficiency
- Your sensitive and confidential documents are safe with us. We use secure file systems, and all our translators work under a binding NDA.
- We meet and exceed translation quality standards, and guarantee our translations will be error-free, or we’ll update them free of charge.
MEDICAL WRITING
Our experience in medical & pharmaceutical linguistics, scientific/medical background, and continued linguistics education ensure the highest possible quality linguistic and consulting services for pharmaceutical, medical device, cosmetic and healthcare industries.
Our Partners
WATER FOR PHARMACEUTICAL NEEDS
PharmConsult LLC is an official representative and service partner of SANEL Zawistowski sp.j. (Poland) in the Republic of Belarus.
SANEL offers complete technological systems for the pharmaceutical and cosmetic industries. The company implements turnkey installations, including design, delivery of materials/equipment among with after-sales service.
SANEL products and services meet the highest hygienic standards. All equipment complies with cGMP, CFR11, GAMP5, Baseline Pharmaceutical Engineering Guide “Water and Steam Systems” Volume 4.
We offer:
- Design of water storage systems, PW and WFI distribution loops
- Implementation of process installations
- Preparation of IQ and OQ qualification documentation and qualification tests
- Production of CIP/SIP stations
- Design of control cabinets
- Qualification of welders with the issuance of international certificates
- Production of heat exchangers and UV-lamps
- Assembly and delivery of control cabinets
- Development of software drivers for PLC and HMI panels
- Installation of piping and facilities on site
- Assembly of electrical and pneumatic systems
- Start-up of an entire system
- Development of comprehensive as-built documentation
- Training
EQUIPMENT FOR PHARMACEUTICAL, FOOD AND COSMETIC INDUSTRIES
PharmConsult LLC is an official partner of the Swiss company Bütler & Partner LLC in the Republic of Belarus.
We are glad to help with qualified selection and delivery of process and packaging equipment for the pharmaceutical, cosmetic and food industries: from laboratory units to complex production plants.
All equipment is designed and manufactured in accordance with the requirements of cGMP, FDA, HACCP, 3A, ISO / CE, etc. It comes with a full set of certificates and technical documentation.
Our partners are highly specialized and internationally successful manufacturers. This allows us to offer a wide product range from water purification PWI over conveying and many process steps like size reduction/milling/grinding, blending/mixing/homogenization, separation/drying to complete packaging solutions. Together with our principals we can offer standard as well as tailored-to-measure equipment and solutions including the required engineering. In most cases we cover pilot plant and production size, in some even laboratory versions.
ACTIVE INGREDIENTS, EXCIPIENTS, REFERENCE STANDARDS
We offer a wide range of products from the manufacturers across the globe
- API
- Excipients
- Reference Standards
- Natural Extracts
- Disintegrants
- Coloring agents
- Sweeteners
- Preservatives
- Taste-masking excipients
- Flavors
Careers
Contacts
Working hours: 9:00 – 18:00 weekdays
Тел.: +375 (29) 677 01 14
info@pharmconsult.org
220114 Minsk, Vaupshasova str., 10-5
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