Comprehensive audits
Мы предлагаем профессиональные услуги по проведению комплексных аудитов для производителей лекарственных средств и биологически активных добавок (БАД).
We also conduct audits of preclinical and clinical research centers. We provide support in preparing for GLP certification and in inclusion in the register of researchers and research centers of the Ministry of Health of the Russian Federation
Our goal
To help businesses ensure regulatory compliance, improve process efficiency, and minimize risks
Outcome
Following the audit, we provide a clear action plan to enhance processes and address identified shortcomings
Trusted by
Позвольте выразить благодарность за ваш вклад в наше сотрудничество, которое оказалось столь плодотворным. Особенно хочется отметить Ваш высокий уровень профессионализма, организованность, четкую формулировку задач и предоставление всей необходимой информац…
За время нашей работы сотрудники МБФ показали свой профессионализм. Компания обладает высококвалифицированными кадрами и современным оборудованием, а также не только следит за качеством выполняемой работы, но и учитывает пожелания заказчика. Рекомендуем МБФ…
Мы благодарим МБФ за разработку и промышленное производство нашей продукции, а также лояльное клиентоориентированное отношение. Команда компании выполнила полный цикл работ – от подбора и отработки состава продукции до ее регистрации и серийного выпуска, – обе…
Frequently asked questions
Our production facility holds a license to manufacture pharmaceuticals, as well as certificates confirming compliance with Good Manufacturing Practice (GMP) rules, the requirements of GOST R 56202-2014, GOST R ISO 9001-2015 (ISO 9001:2015), and GOST R ISO 22000-2019 (ISO 22000:2018 HACCP). When conducting clinical and preclinical studies, we adhere to the requirements of good practices GCP and GLP.
You can view MiraxBioPharma’s current licenses and certificates here.
We ensure quality control at every stage of production through:
- strict adherence to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and International Organization for Standardization (ISO) guidelines;
- advanced equipment that enables a wide range of testing for raw materials and finished products at all stages of production.
In addition, the high quality of our products is supported by collaboration with trusted suppliers and the use of high-grade raw materials and components throughout the entire manufacturing process.
Our production facility is located in the Moscow region, in Khimki, at the following address: Rabochaya Street, building 2A, building 1. It houses modernized production areas, a research center, and our own laboratory complex.
Each batch of products is accompanied by a certificate of analysis confirming its quality and compliance with regulatory documentation.
Our services
Production audit
Supplier audit