With focus on the unique needs of each client we are helping, offering and providing pharmacovigilance and regulatory services throughout all phases of the product lifecycle to deliver quality, safe and efficient products on the European market. We are ready to represent you in the following areas:
We will be your trustable partner to ensure quality and safety products on the market. We are able to provide you with unique support and services tailored especially to your product portfolio and project needs.
EU QPPV/Local PV Contact
We act as your European or Local contact person for monitoring of drug safety on the market in EU/ Czech Republic.
We help you to establish the full pharmacovigilance system (PSMF), including appropriate SOPs
Entrust us with your responsibility to appropriately report adverse events and reactions accordingly.
We will monitor for you literature research and on regular basis to fulfill obligations. We will check also the respective news in pharmacovigilance area to ensure the up-to-date status.
We are ready to train you on the pharmacovigilance basis and provide you annual training for all your employees.
Full expertise in regulatory affairs allows us to reach your goals in all stages from pharmaceutical development to medical product launch and help you to continue smoothly throughout the maintenance phase of the product lifecycle.
Dossier audit or gap analysis
Submission of the suitable dossier can avoid future deficiencies raised by the authorities during the procedure. That is why resolving technical discrepancies prior to the submission save time and cost delays.
We create, discuss or implement your regulatory strategy to ensure a product launch in timely manner, following necessary guidelines and considering relevant costs.
We collaborate with your manufacturing site(s) and other experts to ensure the presented dossier is suitable for the submission containing relevant parts of Module 1-5.
We assembly and complete regulatory dossier that enables you to handle electronic submissions, build, view, validate and publish required submission format of eCTD and keep track of all changes and updates to life cycle documentation
We ensure dossier delivery by the relevant portal (CESP) or personally to the agency, giving you feedback and collaborate on any validation issues raised by the authority.
We monitor the progress of the submission with relevant authorities, keeping you fully informed about any deficiencies addressed with regards to your procedure.
We ensure the dossier compliance by submission of relevant variations, renewals to the authority to keep the documentation up to date.
Communication with Authority
We act as your local contact person in the Czech Republic or communicate wth authorities on behalf of applicant within EU.
Marketing advertising approval
We assess and approve your promotional materials in accordance with the latest approved package information, considering the regulation of marketing claims.
We are here to support you in case of compliance improvement needs, to establish tailored made quality system manual and maintenance the quality by regular audits.
We perfom internal audits of the documentation (Company policies, Standard operating procedures, Working Instructions…etc.) with the aim to verify established processes.
Quality System Management
We help companies to establish an efficient quality management system (QMS). Propose and prepare a robust system of SOPs in accordance with the latest requirements.
We are qualified for the role of Qualified Person (QP) as per Directive 2001/83/EC and take responsibility to release a batch to the distribution.
We help you to identify potential deficiencies in processes and prepare corrective measures and analysis for improvement.
We are ready to provide specific training to cover your need and prepare annual trainings for your employees.
Risk Management Plan
We are experienced in medical writing of Risk Management Plans (RMPs) to cover safety development of the product.
We will prepare for you PSURs, the accumulated information on a given product and present it in a systematic order to check-up on a drug’s or substance’s safety.
We write the Clinical Overview (CO) a vital part of the Common Technical Document (CTD), that describe critical, appropriately supportive assessment of the data that has to justify the proposed Summary of Product Characteristics (SmPC).
We prepare the preclinical evaluations that are the key component of drug development. Non-clinical report is in comprise a comprehensive scientific programme that spans the whole lifecycle of the compound.
Other Medical Support
We support you in case of any other need to write specific regulatory document related to clinical evaluation, similarity of medicinal products, addendums for renewals or clinical summaries.
Preparation of instructions for use
We check or prepare instructions for use in the Czech language laying emphasis on its essential contents for the purpose of the product notification.
Notification with CPNP
We support companies who intents or supply cosmetics on the market in the Czech Republic to submit an application for notification of their products. And we also communicate with Authority on their behalf with the aim to get an approval letter.
Notification with Registry of Medical Devices
We support companies who intent or supply medical devices on the market in the Czech Republic to fully comply with the new MDR legislation. their behalf with the aim to get an approval letter.
We give you our expertise on the acceptable product status in the Czech Republic based on the product composition and intended use. We also communicate the issues with relevant authorities.
Notification with Authority
We ensure the product notification with the relevant authority in order to be marketable in the Czech Republic.
Labelling & health claims
We prepare, assess or correct your labelling in accordance with EU regulation also incorporating additional parts as per Czech requirements.