Services

Registration actions:

• submit the dossier to the registration agencies,
• closely monitor the registration process and speed it up by reacting immediately to possible problems,
• respond in verbal or written form to any questions raised by the registration agencies,
• prepare official responses to the deficiency letter,
• scientifically support the company in discussions with the representatives of the registration agency,
• take over and continue the registration process.

Pre-registrations actions:

• choosing the appropriate procedure,
• deciding on the type of application
• deciding on the form and content of the dossier,

preparing all or part of the registration documentation according to the requirements of specific registration agencies, including:

• declarations templates
• proper justification for types of application (Module1.5.1, 1.5.2),
• expert reports on Environmental Risk Assessment (Module 1.6),
• Pharmacovigilance (Module 1.8.1, 1.8.2)
• Clinical Overview and Clinical Summary (Module 2.5, 2.7) together with the prepartion of  Module 5,
• Non-clinical Overview and Non-clinical Written and Tabulated Summary (Module 2.4, 2.6) together with the preparation of Module 4,
• Full Module 3 together with the Quality Overall Summary,
• preparing/evaluating/translating of the Summary of Medicinal Product, Patient Information Leaflet and Labeling,
• preparing the documentation in eCTD format
• evaluating the dossier indicating the deficiencies

• preparation of documentation into NEES or eCTD
• prepare professional registration or variation dossier in eCTD or NEES format,
• reformat existing NtA/CTD dossiers to eCTD/NEES format

management of dossiers in eCTD, particularly for:

• monitoring the status of all submitted variations,
• presenting, at any chosen moment, the up-to date dossier with currently approved variations.

drug Life Optimization is an all-encompassing business approach to manage the complete set of product information, processes, and resources in order to maximize the longest, full life potential of a drug.

By gaining an understanding of clients’ commercial needs, the key decision makers and route to market, we are able to recommend market access solutions which help our clients bring their products efficiently to market.

• comprehensive individual case safety reports management (receipt, tracking, processing, MedDRA coding, medical analysis and assessment, follow-up, reporting),
• PSUR generation and prompt submission to Competent Authorities,
• preparation of Addendum to Clinical Overview,
• weekly literature searches and preparation of comprehensive reports,
• advise on or complete registration process to EudraVigilance,
• electronic reporting to EMA and competent authorities (via EVWEB or company’s gateway),

• responsible person for EudraVigilance – the person who represents the company in registration process,
• entering and maintaining of product information in XEVMPD,
• preparation of Pharmacovigilance System Master FIle (PSMF) tailored to company’s needs, based on our PV system (Module 1.8.2 of registration dossier),
• prepariation of Risk-management plans for specific products (Module 1.8.2 of registration dossier),
• Pharmacovigilance audits: assessment of company’s system, indicating deficiencies and advise on needed improvements,
• acting as Local Pharmacovigilance Contact points we ensure compliance with polish legal requirements

provides a full support on clinical project management, monitoring, data management, and statistical analysis for clinical trials. Dedicated to the quality service, SciencePharma helps the clients to reduce time-to-market costs and risks while maintaining strict compliance with all regulations and by using state-of-art operating procedures.

A European Directive which came into force in 2005 requires marketing authorisation holders of medicines to have all patient information leaflets for their products readability tested, ensuring that product information is legible, clear and easy to use.

A European Directive which came into force in 2005 requires marketing authorisation holders of medicines to have all patient information leaflets for their products readability tested, ensuring that product information is legible, clear and easy to use.