Services

MAXIMA Health Research can provide service and act as a consulting agent in the field of regulatory support in all CIS countries.

  • Completion of documents, required for product registration
  • Collecting and handling the dossier for the primary registration/renewal/inclusion of changes according to the legislative requirements
  • Support of all the stages and procesess of registration in the local agencies and authorities
  • Development, approval and implementation of various types of packaging and local labeling in the manufacturing process
  • Applications to patent authority, support for patent protection and protection of trade names at the different stages

Services

MAXIMA could provide service and act as your consulting agent in all CIS countries.

Pharmaceutical products

Pharmaceutical products (pharmaceuticals, medicines, drugs) - a substance or a mixture of substances (one or few active pharmaceutical ingredients (API) and excipients), which are specified and used for prevention, diagnosis and treatment of diseases in humans, or for prevention of pregnancy as well as to improve and to change physiological states or physiological functions under pharmacological or metabolic effects.

Pharmaceutical products include: active pharmaceutical ingredients, in bulk  products, ready made dosage forms, active substances (medicine, medication, medicinal product), detectors of disease agents or insecticidal agents (the means to fight pathogens or parasites), homeopathic remedies, medical cosmetics, treatment additives for food.

Biologic medical  products

Biologic medical  products – allergens, antigens, vaccines (toxoids), cytokines, immunomodulators of bacterial origin or those based on extraction of substances from biological organs and tissues, products obtained from human blood and plasma, serums, immunoglobulins (including homogeneous  antibodies), probiotics, interferons, other medicinal products used for treatment of diseases in humans, specific prevention and diagnosis of immune system condition (in vivo).

General requirements for registration process of Pharmaceutical/ Biologic medical products

Medical Device

Medical devices - any equipment, facilities, systems, apparatuses, vehicles, tools, devices, implants, materials or other products, including invasive materials and materials that do not reach the expected target in the human body or on it by pharmacological, immunological or metabolic means, but the functions which such tools can contribute; products which are used both separately and in combination with each other, including the software necessary for its proper use, provided by the manufacturer for:

  • prevention, diagnosis, treatment, monitoring or facilitation the patient's condition in case of illness, injury, damage and their compensation;
  • research, replacement or modification of the structure (anatomy) of organs, tissues or physiological processes;
  • control of fertilization.

Any equipment or supply that comes with medical device and is designed to integrate with other external (additional) equipment, should be regarded as an integral part of medical product. Medical products for diagnostic in vitro - reagents (or equivalent substances), products of the reagents, calibrators, reference materials and related products, instruments and devices, laboratory materials, tools, tool sets, vehicles, equipment, systems, which are used separately or in combination with each other and designed by manufacturer for in vitro studies of samples of waste products or samples of the human body, including blood, microbiological, virological materials and tissue (histological) samples to obtain information concerning:

  • physiological state or presence of pathological
  • congenital anomaly
  • determination of safety and compatibility with potential recipients
  • overseeing treatment
  • containers for storage of samples belong to the medical products for diagnostics in vitro. Tanks for storage of samples - are products, including the vacuum type, which are designed by manufacturers for primary containment and storage of samples obtained from the human body to diagnose in vitro
  • products for general laboratory usage are not relevant to medical products for diagnostics in vitro, except those, whose characteristics are specifically designed by manufacturers to use in diagnostic studies in vitro

General requirements to registration documentation

Biologically active substances

Biologically active substances and special food products - products that are intended for nutrition and made in special combination or in a special way and is definitely different from those for conventional food products; having a definite direction of usage. Direction of usage must comply with the requirements and categories of people, who will use these products, such as characteristics of digestion, specific physiological conditions (for children and infants). In this case, these products may have a positive effect with controlled usage. Directive 89/398/EEC

General requirements to registration documentation

Cosmetics

Cosmetics - Any substance or product which can be in contact with various external parts of the human body with the sole purpose (or to achieve several goals), such as cleaning, deodorization, altering of the appearance, odor, protect or maintain in proper condition.

General requirements to registration dossier

 

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