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REGISTRATION
PHARMACOVIGILANCE
CLINICAL TRIALS
OVER 12 YEARS
consulting pharmaceutical companies in the EAEU and CIS
We provide consulting and expert services
Registration of Pharmaceuticals, Dietary Supplements, and Medical Devices
PHARMASSISTANCE IS
- Pvider of regulatory services, medical research and pharmacovigilance services
- We provide a range of services in the EAEU and the CIS
- Professional and highly qualified team of experts
- Reliability and quality assurance: more than 12 years in the regulatory market
- Individual approach to each client
EXPERIENCE
12
years in the research services market
+150
successfully completed projects annually
+800
executed regulatory activities
Новости рынка
Our Experience
PharmAssistance LLC is a dynamically developing company providing consulting and expert services to pharmaceutical organizations operating in the CIS and the Eurasian Economic Union. The main areas of our activity are: pharmacovigilance from scratch, registration of medicines and medical devices in accordance with the requirements of the legislation, clinical trials of medicines and non-interventional studies.
We have been operating since 2012 and during this time we have gained a strong position in our segment. Today, we have more than 150 successful projects per year and more than 800 ongoing activities, as well as many testimonials from grateful clients.
Close cooperation with research laboratories and centers, specialists in the field of science and authorized registration authorities allows us to react quickly to non-standard situations and solve cases of any complexity. Today you can also use our services: call us, we are looking forward to new cooperation!
Conducting clinical trials of medicinal products in collaboration with PharmAssistence
Clinical medicine trials are conducted to analyze the safety and efficacy of new medicines, as well as to identify new pharmacological properties of existing medicines.
Conducting a clinical trial with our experts consists of the following steps:
- Provide the client with up-to-date information on the latest clinical trials;
- Assisting in the timely preparation of the package of documents;
- Organizing clinical trials of medicines;
- Providing information support during each phase of clinical trials;
- Monitoring and analysis of clinical trials;
- Preparation of study reports.
Development and registration of medicines, medical devices and biologically active supplements
In order for a medicinal product, dietary supplement or medical device to enter the market, it must be registered. The procedure of medicinal products registration by our specialists includes the following activities:
- Advising and developing a registration strategy;
- Formation and verification of the registration dossier for submission to the regulatory authorities;
- Preparation of the necessary technical documentation package;
- Mediation services in cooperation with testing clinics and laboratories;
- Informational support by our specialist to ensure that the registration of medicinal products in the EAEU and CIS has a positive result;
- Representation of client’s interests in regulatory authorities;
- Obtaining a registration document (the client receives a certificate of state registration of a dietary supplement, medical device or medicinal product).
Organization of pharmacovigilance by specialists of PharmAssistance LLC
We offer a wide range of services that the pharmacovigilance system provides:
- Organization of the company’s pharmacovigilance;
- Maintenance of the established mechanism;
- Pharmacovigilance audits;
- Performing routine activities as an authorized person or contact person for pharmacovigilance for each product registered in the territory of the Eurasian Economic Union.
We ensure that all drug safety information is collected in a timely manner and communicated to all stakeholders in an appropriate time frame.
Non-interventional studies facilitated by our company
A non-interventional study is a medical study conducted without any outside intervention. We offer the following services:
- Assistance in developing medical records;
- Research center searches;
- Assistance with all phases of the study;
- Assistance in writing the final publication.
PharmAssistance - We work with you, you trust us!
Our goal is to provide a professional, personalized and efficient approach to solving any problem. We strive to work in such a way that you would not be ashamed to recommend our services to your acquaintances. We offer our clients
- Assistance in solving cases of any complexity;
- A team of top managers with many years of experience in the successful implementation of pharmaceutical projects;
- Close ties with professional organizations in the field of clinical research and medicine development;
- A wide geography of services;
- Up-to-date knowledge that we constantly update;
- individual, client-oriented approach;
- 100% process control and guaranteed results;
- full confidentiality.
We are always open for new cooperation! We will be glad to see you among our clients!
