Our Services
PHARMACOVIGILANCE SYSTEM SET-UP AND MAINTENANCE
Our knowledgeable staff at Navatio Pharma is available to assist you in setting up your own pharmacovigilance system or enhancing your current one. Navatio Pharma will identify the best options for your business and the safety profile of your product while adhering to the most recent pharmacovigilance regulations. In relation to your product and patient safety, we will assist you in identifying the relevant internal and external communication channels and stakeholder duties.
In order to keep your pharmacovigilance system (PSMF) up to date and fully compliant with all relevant US and European laws, Navatio Pharma can develop and manage your PSMF and make sure your system is always ready for an inspection.
Navatio Pharma has a comprehensive quality and pharmacovigilance system in place. We can produce and review your standard operating procedures (SOPs) and other quality-controlled operating instructions required for the process if you need to build a new system or enhance your current one. We are prepared to construct your system for herbal and human pharmaceuticals thanks to our wealth of experience.
Navatio Pharma can provide a customizable document management system, letting you focus on your direct responsibilities. With our system, you can manage your documents and their processes with the highest possible efficiency and security.
LOCAL PHARMACOVIGILANCE ACTIVITIES
Navatio Pharma’s dedicated and experienced team provides local QPPV and contact person services with in-house resources and expertise, combined with local safety teams.
Local services include
⦁ Local contact person
⦁ ICSR intake and local- case processing
⦁ Local literature reviews
⦁ Local submissions (such as aggregate reports, RMPs and ICSRs)
⦁ Compliance monitoring
⦁ Fulfilling local PV requirements in relevant procedures and systems
⦁ PV training
⦁ Regulatory authority inspections
⦁ Medical information services (link to MI services)
⦁ Translations
LITERATURE AND SOCIAL MEDIA SCREENING
Literature monitoring is a key element of any pharmacovigilance system. Navatio Pharma can manage your global and local literature screening as well as monitor the EMA’s Medical Literature Monitoring (MLM) service, complete with text review and assessment of safety information.
Our search is not only limited to identifying individual case safety reports, but also includes detection of potential safety issues. Each search includes evaluating the significance of the hit concerning periodic safety reports. Literature screening supports your signal management process, including development and management of the benefit-risk profile of your product.
Company social media sites require screening by the marketing authorisation holder. Navatio Pharma can assist you in following the relevant discussions on social media.
SIGNAL MANAGEMENT
Navatio Pharma can provide clinical trial and post-authorisation case processing. Our in house experts will perform triage, data entry, MedDRA/WHODrug coding, narrative writing, medical evaluation and expedited reporting of ICSRs. In addition to the USFDA, Navatio Pharma can also process your reports for pharmacovigilance systems in the United Kingdom, EU/EEA, and Canada.
Our case processing activities are always tailored to your needs, from receiving and forwarding reports to complete case processing, including submissions to the competent authorities.
Our service portfolio includes a validated cloud-based safety database PVZen and the services of in-house safety physicians. Our Pharmacovigilance Data Management Team can provide cost-effective solutions to manage and process your ICSRs. Navatio Pharma can provide safety management of your post-authorisation studies, including full case processing, signal detection and cumulative safety analysis.
Benefits of the PVZen database:
⦁ Continuously up to date with the latest regulatory requirements
⦁ Direct gateway connections for EMA and FDA submissions
⦁ Powerful real-time reporting and dashboards
⦁ ICH E2B (R3) structure alignment
⦁ Secure, compliant and validated in accordance with FDA 21 CFR Part 11 Electronic Records, Electronic Signatures and EudraLex Annex 11: Computerised Systems
LOCAL PHARMACOVIGILANCE ACTIVITIES
For continuous and periodic signal detection and management, Navatio Pharma has in place robust procedures in accordance with GVP Module IX: Signal management and FDA’s Guidance on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.
Our experienced team with safety phycisians continuously reviews existing data to detect and subsequently evaluate safety signals from various sources, including the following:
- Global safety database listings and tabulations
- Information from literature screening (such as class effects and potential drug interactions)
- Emerging pre-clinical findings (such as teratogenic analyses and effects on pregnancy)
- Blinded/open label clinical data (such as Data and Safety Monitoring Board (DSMB) summaries and clinical study reports)
- Regulatory agency information (such as Pharmacovigilance Risk Assessment Committee (PRAC) findings and FDA notices)
- Information from partners
- EudraVigilance Data Analysis System (EVDAS), FDA Adverse Event Reporting System (FAERS) and information available from other regulatory databases
- Competitor product information.
When needed, Navatio Pharma can arrange safety review meetings with key stakeholders from the MAH’s organisation to discuss these safety findings and decide the appropriate actions.
AGGREGATE SAFETY REPORTS
Let us ensure continuous monitoring of your medicinal products’ safety profile. We can handle your aggregate safety reporting obligations throughout the product lifecycle, from development to market, by writing:
- Development Safety Update Reports (DSURs) Link to clinical safety
- Periodic Safety Update Reports (PSURs), Period Adverse Drug Experience Reports (PADERs) and Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Addendums to the Clinical Overviews (ACOs).
With our comprehensive experience, including writing over 300 PSURs and PADERs, Navatio Pharma can prepare all line listings, frequency tabulations and trend reports, as required, or propose additional solutions and customisable reports according to your needs.
We continuously follow the changes in legislation and ensure that submissions are always compliant and done according to the regulatory timelines.
RISK MANAGEMENT AND RISK MINIMISATION ACTIVITIES
The risk management plan (RMP) describes the risk management system and contains information about identified risks, potential risks and missing information regarding a medicinal product. It outlines any risk minimisation measures adopted and includes information about monitoring the effectiveness of these measures. An effective risk management system is a critical part of pharmacovigilance and patient safety.
All new applications for medicinal products within the European Union and UK require submission of a RMP to the European Medicines Agency (EMA) or the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
The United States Food and Drug Administration (FDA) may request a risk evaluation and mitigation strategy (REMS) which is essentially a risk management plan that includes one or more elements aiming to ensure that the benefits of a drug outweigh its risks. Risk management is a key factor in FDA’s risk-benefit assessment. As a whole, risk management consists of both risk assessment and risk minimisation: it is an iterative process involving assessing a drug’s benefit-risk balance, developing and implementing tools to minimise the drug’s risks while preserving its benefits, evaluating tool effectiveness and reassessing the benefit-risk balance, and making adjustments, as appropriate, to the risk minimisation tools to further improve the benefit-risk balance.
To ensure compliance and improve patient safety, Navatio Pharma’ risk management experts and safety phycisians can identify new safety concerns and propose appropriate and effective risk minimisation measures for your products on your behalf.
In cooperation with the marketing authorisation holder, our experts write and submit product-specific risk management plans, risk evaluations and REMSs to the competent authorities at the time of marketing authorisation application or whenever relevant information is updated. We will keep your RMPs and REMSs up to date with the applicable requirements and information collected about the product.
Our experts can plan the additional risk minimisation measures, their implementation and evaluation of their effectiveness for you. With its extensive regulatory and pharmacovigilance network, Navatio Pharma can efficiently modify your documents according to the local regulatory requirements.
PHARMACOVIGILANCE AGREEMENTS (PVA)
Marketing authorisation holders (MAHs) may outsource or delegate any activities related to distribution, marketing, sales or pharmacovigilance to another party. In such cases and if there is any chance of receiving new safety information, a pharmacovigilance agreement (PVA) must be in place. The PVA indicates the pharmacovigilance responsibilities of each party. When you need help in allocating the right responsibilities to the responsible parties, Navatio Pharma can help.
A safety data exchange agreement is a legal written agreement that requires different stakeholders (such as manufacturers, distributors and partners) to exchange all safety data for medicinal products with marketing authorisation holders. The MAH must therefore clarify the applicable responsibilities in the agreement to ensure that the European Qualified Person for Pharmacovigilance will be kept up to date with all safety issues and emerging safety concerns in real time.
With our extensive experience in creating pharmacovigilance agreements and safety data exchange agreements, we can draft your agreements with the relevant business partners (such as associated manufacturers, marketing partners, distribution networks or vendors) with responsibilities, communication channels and methods for the exchange of safety information clearly established.
PHARMACOVIGILANCE AUDITS
Pharmacovigilance (PV) audits are designed to verify the appropriateness and effectiveness of the implementation and operation of a PV system, including its quality system. Navatio Pharma has dedicated and knowledgeable auditors to conduct audits that meet the global pharmacovigilance requirements.
Our audits cover the entire PV system, including case intake, adverse event processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing, signal and risk management and clinical safety. Audits of your affiliates, license partners, service providers and distributors, as well as due diligence audits, can be included in our PV audit service.
Implementing a risk-based approach to PV audits and creating the right audit strategy, effective audit program and robust CAPA management system with Navatio Pharma results in a fully functional, high-quality PV system that complies with global regulations.
MEDICAL INFORMATION SERVICES
If you need an expert medical information team to handle your company’s medical information call center in US, UK, Europe and ROW, Navatio Pharma is here to help. Our services cover both pharmaceuticals and medical devices and are fully compliant with national legislation. We will help your company set up, maintain and develop the required functions. Close cooperation and open communication ensure a smooth workflow and efficient processes.
Ongoing quality control activities are part of our processes. By outsourcing your company’s pharmaceutical information functions to Navatio Pharma, you will have access to a resource-saving high-quality service solution tailored to your needs.
Our service-minded and patient safety-oriented team ensures that all inquiries are answered promptly and that responses are based on accurate and up-to-date product information.
Navatio Pharma’s medical information services include:
- Telephone and email services
- Professional customer service
- Immediate responses to questions
- Forwarding questions without intermediaries to company-designated contacts
- Processing adverse reaction reports and forwarding them to your pharmacovigilance unit
- Forwarding product defects and product complaints to your quality assurance unit
- Monitoring of reporting timelines
- Acting as an effective and proactive link between your company and healthcare staff or patients
- Translation services
VETERINARY PHARMACOVIGILANCE
Within the veterinary pharmaceutical sector, pharmacovigilance plays an equally critical role as it does in human medicine. Guaranteeing the safety and efficacy of veterinary products stands as a top priority for promoting animal health and well-being.
At Navatio Pharma Research Organization, we specialize in delivering a comprehensive range of Pharmacovigilance and Real-World Services meticulously crafted to meet the distinct requirements of veterinary companies. Our dedicated efforts aid in the continuous monitoring, thorough assessment, and enhancement of the safety and efficacy standards for their products. We extend our expertise across various veterinary subspecies, including Avian, Canine, Feline, Aquatic, Farm, Wildlife, Reptilian, Exotic, and more..
Services Overview:
MEDICALCOSMETOVIGILANCE
Cosmetic product:
Any substance or preparation intended to be placed in contact with the various external parts of the human body for cleaning, perfuming, to change the appearance, protecting or keeping them in good condition.
Cosmetovigilance:
Cosmetovigilance is a new concept of safety monitoring of cosmetic products which refers to post marketing surveillance of any health-related undesirable effects possibly due to the use of cosmetic products.
The purpose of Cosmetovigilance is to collect, analyze and assess the adverse reactions occurring in consumers to identify any potential health risks, thus guaranteeing a further strengthened safety for consumers.
Importance of Cosmetovigilance:
Cosmetovigilance is especially important because the safety and clinical trial testing of cosmetic products are under less scrutiny by regulators than other products such as drugs, natural health products and medical devices.
The effectiveness and safety of cosmetics are entirely left to the discretion of the manufacturer, which may include testing and with a proper system in place problems can be identified early and changes made, limiting the size of the population affected.
What effects can proper Cosmetovigilance have on industry:
Keeping track of adverse effects from cosmetics is what can often lead to certain ingredients being restricted or prohibited by regulators. Manufacturers may even choose to pull a product from shelves if an increasingly high number of complaints is received. If consumers are seen to experience sensitizing effects from certain ingredients the rules surrounding that ingredient may be amended. In short, without proper cosmetovigilance, vital changes to both product availability and regulation would be less frequent.
Regulatory reporting Timelines:
Europe:
SUEs must be reported to the NCA of the country as soon as possible and in any case no later than 20 calendar days following the date of initial receipt of the SUE.
Association of Southeast Asian Nations Cosmetic Directive:
Fatal or life-threatening Adverse events:
Fatal or life-threatening adverse event qualify for very rapid reporting to the regulatory authority, which shall be notified as soon as possible but no later than 7 calendar days after first knowledge, followed by completing the adverse cosmetic event report form within an additional 8 calendar days and providing any other information as may be requested by regulatory authority.
Other Serious Adverse events:
All other serious adverse events that are not fatal or life threatening must be reported as soon as possible, but no later than 15 calendar days after first knowledge.
FDA:
These are voluntary reports. There is no required timeframe for submission.
Our experts can manage the compliance with cosmetic regulations worldwide ensuring the safety of your product.
