Imis Pharma company offers the whole pharmacovigilance services or provision of particular services.
Our offer includes :

•  preparation (in accordance with applicable legislation) of Pharmacovigilance System Master File (PSMF) its summary (Module 1.8.1.) and related Standard Operating Procedures (SOPs) as well as its regular updates;
•  management of adverse drug reaction reports (registration, analysis, preparation of assessment by Naranjo algorithm, submission to Regulatory authority, collecting information and preparation of follow-up report);
•  ensuring 24/7 receipt of adverse drug reaction reports;
•  preparation of regular local polish literature surveillance and review of medicinal databases;
•  preparation of local literature surveillance outside Poland territory (in the following countries: Armenia, Azerbaijan, Belarus, Bulgaria, Czech Republic, Denmark, Georgia, Germany, Lithuania, Slovakia, Russia, Tajikistan, Turkmenistan, Hungary and others);
•  preparation of Periodic Safety Update Reports (PSURs), including PSURs in NesS format;
•  submission of PSURs to the Regulatory authority in PSUSA procedure via eSubmission Gateway;
•  preparation and regular updates of Risk Management Systems (Module 1.8.2.);
•  EudraVigilance database support: MAH registration and data management, electronic reporting of Individual Case Safety Reports (ICSRs), submission of information on medicinal products (XEVMPD);
•  support for SMEs (micro-, small- and medium-sized enterprises) - registration and renewal;
•  support for MedDRA (assistance in purchasing subscriptions and its renewal, coding);
•  services of Qualified Person Responsible for Pharmacovigilance (QPPV);
•  medical support for QPPV;
•  acting as a contact point between Marketing Authorisation Holder and Regulatory authorities;
•  signal management;
•  creation and maintenance of medicinal product adverse drug reaction reports register;
•  pharmacovigilance system audits;
•  training of employees in the pharmacovigilance field;
•  preparation and support in the distribution of safety communications;
•  monitoring of guidelines, directives, regulations and communications in the field of pharmacovigilance published at EMA and local agencies websites;
•  data storage and archiving along with professional protection against loss;
•  pharmacovigilance consultations with an experienced expert.

Imis Pharma company offers the whole pharmacovigilance services or provision of particular services.
Our offer includes :

• preparation (in accordance with applicable legislation) of Detailed Description of the Pharmacovigilance System (DDPS) and related Standard Operating Procedures (SOPs) as well as its regular updates ;
• management of adverse drug reaction reports (registration, assessment by ABON method, submission to regulatory authority, collecting information and elaboration follow-up report);
• preparation of regular local literature surveillance and review of medicinal databases;
• preparation of Periodic Safety Update Report (PSUR);
• preparation and regular updates of Risk Management Systems (RMS);
• EudraVigilance Veterinary database support: registration and data management, electronic reporting of Individual Case Safety Reports (ICSRs) and submission of information on veterinary medicinal products (XEVMPD);
• services of Qualified Person Responsible for Pharmacovigilance (QPPV vet);
• medical support for QPPV vet;
• acting as a contact point between Marketing Authorisation Holder and Regulatory autorities;
• creation and maintenance of veterinary medicinal product adverse drug reaction reports register;
• signal management;
• pharmacovigilance system audits;
• training of employees in the pharmacovigilance field;
• monitoring of guidelines, guides and communications in the field of pharmacovigilance showing at the sides of EMA and local agencies;
• preparation and support of the distribution of safety communications;
• data storage and archiving along with professional protection against loss;
• consultation with a selected range of pharmacovigilance with an experienced expert

Imis Pharma company offers support for sponsors and CRO companies in the pharmacovigilance in clinical trials on the basis of applicable regulation.
Our offer includes:

• access to the professional adverse drug reaction database;
• preparation of Safety Management Plan;
• preparation and management of SAE & SUSAR;
• preparation of Development Safety Update Report (DSUR);
• preparation of Final Safety Report;
• signal detection;
• Eudravigilance database management;
• 24/7 support of person responsible for receipt of SAE &SUSAR.

Imis Pharma company provides whole cosmetovigilance services or offers particular activities from the cosmetovigilance field.

Our offer includes:

• ensurance of responsible person;
• preparation and implementation of standard operating procedures;
• elaboration und updates of distributors database;
• preparation of responses for consument queries relating to cosmetic product safety;
• assessment of received adverse reaction report;
• submission of adverse reaction report to relevant authorities;
• maintenance of cosmetic product adverse reaction register;
• preparation of safety report in accordance with Commission Implementing Regulation 2013/674/EU;
• staff training in the scope of receipt and handling with adverse reaction reports induced by cosmetic products;
• ensuring 24/7 contact point for receipt of cosmetic products adverse reaction reports;
• data storage and archiving along with professional protection against loss.

Imis Pharma company offers elaboration of clinical documentation and whole pharmacovigilance services for medical devices or provision of particular services.
Our offer includes:

• elaboration of standard operating procedures (SOPs);
• ensurance of 24/7 contact for receipt of adverse incidents involving medical devices;
• submission of incidents involving medical devices to relevant authorities;
• staff training in the field of medical devices safety;
• data storage and archiving along with professional protection against loss;
• preparation of field safety notices;
• preparation of clinical evaluation.

Imis Pharma company with a headquarter in Warsaw provides local representation for marketing authorization holders outside Poland territory.
Our offer includes:

• ensuring contact person for Polish Regulatory authorities, institutions and agencies;
• correspondence on behalf of marketing authorization holder (receipt, translation, forwarding, submission);
• support in searching of distributors or other contractors in Poland;
• conducting and supervising of medicinal product registration on behalf of Maleting Authorization Holder;
• pharmacovigilance local services;
• tracking and submission information on changes in local guidelines and information on the published recommendations and communications concerning business area.

Our company specializes in supervision of registration processes and post-authorisation variations for medicinal products, notification of medical devices and dietary supplements in accordance with local or European legislation.

We provide the initial assessment of the dossier, including its chemical, pharmaceutical, pharmacological, toxicological, clinical and non-clinical parts and bioequivalence studies.

In addition to this we conduct switches from Rx to OTC, and renewals.

We provide consulting services encompassing granting of medicinal product licence in terms of determining the registration requirements, planning of clinical / non-clinical studies. We help in choosing the type of application for the generic products or products containing well-established use substance .

We provide support in the preparation of PIL, SmPC and labelling content, its adjustment to current QRD templates and its verification before final printing.

In line with the current legislation, marketing authorisation holder is obliged to conduct regular audits on their Pharmacovigilance systems including risk based audits on their quality systems.

Imis Pharma company offers conduction of independent audits encompassing whole Pharmacovigilance system, as well as its indicated elements.

Each audit is usually conducted by two independent, professional auditors with years of experience in the pharmacovigilance area, what guarantees its effectiveness, quality and objectivity.

As a part of our offer, we propose different types of audits, depending on your requirements:

• direct audits (visit of our auditors at your company);
• remote audits (conducted via telephone/teleconference with the electronic exchange of documentation);

Each audit, regardless of its type, is conducted on the basis of previously agreed audit agenda. Results of an audit are documented and forwarded in the form of a report. If necessary, we ensure support with the implementation of corrective and preventive actions, including conduction of follow-up audit.

Imis Pharma company provides professional, medical translations from English, German and Russian, as well as translations from Polish to the above mentioned languages.

As part of our offer, we mainly translate medicinal products documentation, medical texts, contracts, product information, system documentation, safety communications, correspondence with institutions and offices, etc.

Employees preparing translations possess medical education, years of experience in translating and confirmed by certificates or linguistic study knowledge of foreign languages, which allows us to deliver translated documents with the highest quality.