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Pharmacovigilance
QPPV Case Processing Safety Database Aggregate Reporting RMP Writing PV System Set-Up PSMF Creation Spontaneous Reports Literature Screening Regulatory Intelligence

QPPV

Many pharmaceutical firms with a non-EU basis, no in-house PV skills, or business choices to concentrate on key strategic competencies seek to externalize these vital tasks. Therefore, outsourcing QPPV in the EU/EEA has several benefits. Biomapas' QPPV solutions include these professionals in the EU and CIS/EAEU Region to manage and maximise PV outcomes effectively.

Case Processing

An effective pharmacovigilance (PV) program must ensure patient safety at all times. Defined as the identification, collection, and processing of Individual Case Safety Reports (ICSRs), all pharmaceutical and biotechnology firms are required to submit to regulatory authorities following stringent criteria and deadlines. With the help of our PV experts, we can guarantee that you meet your case processing needs.

Safety Database

Biomapas Pharmacovigilance specialists utilize Vault Safety powerful tool for collecting, managing, and providing real-time oversight of adverse events for more informed decisions and improved compliance. In addition, it features streamlined adverse event management with role-based assignment and routing of safety cases for follow-up and medical review.

Aggregate Reporting

Our staff at Biomapas works vigorously to guarantee accurate and compliant aggregate safety reports. As pharmacovigilance and aggregate safety report writers, we have a wealth of experience from pharma and biotech, authorities, and academics. We also provide you with guidance on aggregate safety data analysis and benefit-risk evaluations to ensure patient safety and well-being.

RMP Writing

The Risk Management Plan (RMP) addresses and summarizes a product's safety and efficacy concerns throughout its lifecycle.  Biomapas' clinical and quality professionals support you in developing and maintaining a high-quality, compliant RMP.

PV System Set-Up

Post-market monitoring is required in the EU/EEA, the US, and other large pharmaceutical markets (MAA). A comprehensive pharmacovigilance system includes a safety database, SOPs, and a network of trained, certified people working with local authorities in local languages. Thus, a PV system needs significant expenditure, which is not always desirable or practical for smaller pharma. Working together with Biomapas' experts allows you to outsource the complete set-up or individual parts efficiently. 

PSMF Creation

A thorough PSMF offers a critical first look into your company's PV system for EU regulatory inspectors. The Pharmacovigilance System Master File is a business-critical document that summarizes the Marketing Authorization Holder's (MAH) PV system. We develop and maintain a PSMF that correctly and completely defines your company's PV system. 

Spontaneous Reports

Spontaneous reporting is an important aspect to pharmacovigilance (PV), relying on the motivation of individuals to report suspected adverse drug reactions (ADRs) to a local or national pharmacovigilance centre. Biomapas' spontaneous reporting system handles Individual Case Study Reports (ICSRs)  helping you detect and confirm safety signals.

Literature Screening

To maintain compliance with regulatory laws throughout the globe, global and local literature screening is essential to discover reportable Individual Case Safety Reports (ICSRs) and detect new safety signals for developing safety concerns. To guarantee that your pharmacovigilance (PV) program complies with worldwide regulatory standards, our expert team at Biomapas can assist you with all of these tasks.

Regulatory Intelligence

The Regulatory Intelligence services provided by Biomapas may help you establish a sustainable drug development program, perform efficient clinical trials, and develop a solid commercialization strategy. A good plan will save you time and money by combining our expertise with publicly available data and data based on our own experience. We help you make strategic choices and get an advantage in a competitive market.

Medical Information
Medical Information Scientist Medical Information Database Medical Communication Analytics & Insights Integrations Full Product Lifecycle Content Creation & Management Around The Clock Global & Local Coverage

Medical Information Scientist

A 24-hour Medical Information Contact Center is accessible to Biomapas customers seven days a week, 365 days per year. Additionally, our workforce comprises seasoned healthcare professionals and life science graduates who act as an extension of your team. In addition, our experts may assist you with case follow-ups and case completion on your behalf. We go above and above to help your customers and patients in every way that we possibly can.

Medical Information Database

Biomapas Medical Information specialists collecting, manage, and provide real-time oversight of so you can make informed decisions and improved compliance.We streamline our efforts with our adverse event management team and apply with role-based assignment and routing of safety cases for follow-up and medical review.

Medical Communication

Pharmaceutical firms must continuously communicate and educate healthcare professionals to enhance patient care. The traditional definition of Medical Information refers to collecting data, generating the content, responding, and evaluating findings. At Biomapas, Medical Communication represents strategic strategies for presenting and disseminating information to your intended audience.

Analytics & Insights

What value can Medical Information activities provide a business to turn a legal obligation into a competitive advantage? Biomapas' Medical Information services provide enormous insights and results with significant strategic potential for pharmaceutical companies and should be a key partner in designing patient experiences. These insights help recognize emerging themes, indicate early problems, and identify high-impact areas for future medical education.

Integrations

We combine our Medical Information expertise with RA & PV in multi-disciplinary teams. As a result, we can offer our clients a combination of in-house expertise and the tools they need to guarantee patient safety.

Full Product Lifecycle

Since the advent of ATMPs and personalized medications, it has become more challenging to provide Medical Information analytics. Due to a combination of high demand, limited resources and growing difficulties in getting new products on the shelves, operations may be severely impacted by this. We offer efficient solutions to ensure contact centre traffic, triage, and response documents are adequately managed consistently and globally.

Content Creation & Management

Your library of critical documentation can be created entirely or seamlessly added to by Biomapas' medical writing experts, who have extensive expertise in various therapeutic fields and academia.

  • Standard Document Creation
  • Custom Response and Content Management
  • Response Document Maintenance
  • Translation and Localization Services

Around The Clock

Our Medical Information staff represents highly-trained experts, which includes multilingual native speakers. In addition, of course, our Contact Center Support is available 24/7/365. Above all, Biomapas aims to put technology first to offer a modern solution that is both high-quality and efficient. 

Global & Local Coverage

Because we have local employees throughout all of the European, CIS, EAEU and MENA regions, we have a high level of regional, cultural, and legal knowledge under the Biomapas umbrella. In addition, as a result of our extensive experience in Clinical Research, Regulatory Affairs, Pharmacovigilance, and Medical Information, we can provide comprehensive solutions.

Clinical Research
Clinical Strategy Early Phase Phase II Phase III Post-Marketing Rescue Studies Authority Interaction

Clinical Strategy

For your trials to be successful, you need to be well-versed in science and technology.  Knowing there is no one-size-fits-all approach to clinical development, we apply an integrated approach to development that leverages our different in-house disciplines. Biomapas' goal is to help you face increasing R&D costs, shorter product lifecycles, and embrace digital transformation in clinical development.

Early Phase

Early Phase Research Unit (BIO1) at Biomapas offers patients and healthy volunteers a comfortable and secure setting. To make things easier for its customers, we assign a project manager to everyone who supervises everything from recruiting to clinical study results.  BIO1's capabilities include:

  • first-in-human and proof-of-concept;
  • single and multiple doses;
  • bioequivalence;
  • bioavailability;
  • drug-drug and drug-food interaction;
  • PK/PD;
  • tQTc studies. 

Phase II

As part of our efforts to assist you to comprehend the complexities of Phase II and III clinical trials, we create unique recruitment strategies for you, engage medical writers, and manage clinical sites to support you. Wherever you are in the world, our clinical project managers keep you informed at every step. While looking for appropriate patients in the EU and Developing Markets, you may benefit from our strong KOL network and patient access.

Rescue Studies

Whatever the situation, Biomapas can help you finish your studies on schedule, improve the quality of your trials, or have your research approved again by a regulatory body.

 

Your research duration, regulatory filings and ultimate commercialization are all affected by these variables. As a result, after evaluating the extent and kind of study management deficit and identifying the sort of repair needed, we may act as a third-party function.

Authority Interaction

During drug development, marketing authorization, or later in the medication's lifecycle, interactions with health authorities may impact your product's outcome and financial success. Meetings with health authorities allow you to fine-tune your development plan with feedback from potential marketing authorization decision-makers. Biomapas prepares you to get the most out of them and informs you of the authorities' priorities, questions, and expectations.

Regulatory Affairs
Strategy & Gap Analysis Dossier Development Dossier Submission EU Support EAEU Support Authority Interaction & Scientific Advice Lifecycle Management Regulatory Intelligence Promotional Materials & Packaging Updates

Strategy & Gap Analysis

Having a solid regulatory strategy is essential to ensuring that your product reaches the market in the fastest possible time. With no plan in place, you'll have no way of anticipating potential problems or deadlines. Decades of combined knowledge and local expertise in regulatory consulting means that Biomapas can create a comprehensive strategy. We provide you with a solid strategy, take care of necessary paperwork, and allow you to predict key milestones confidently. 

Dossier Development

Scientists with PhDs in biomedical sciences, who have worked in the pharmaceutical business, clinical research organizations, or academic institutions, compose our medical content. In addition, medical Writers from Biomapas may assist you with creating documentation that is needed in clinical research, regulatory affairs, or for scientific reasons, among other things.

Dossier Submission

Throughout Europe, Biomapas offers local regulatory affairs assistance to customers in pre-approval and post-approval regulatory affairs.

It is the goal of our complete spectrum of Regulatory Affairs solutions to provide our customers with an outstanding level of support, help, and regulatory approvals. We use rapid, efficient, and cost-effective working methods to get the job done quickly and efficiently.

EU Support

We have assisted our clients in obtaining more than 150 Marketing Authorizations through National Procedures. Over the past few years, we have executed more than 1,000 regulatory submissions on our clients' behalf. Additionally, we were/are involved in more than 25 marketing authorization processes for medical products, including centralized, decentralized, and mutual recognition procedures.

EAEU Support

If you are interested in marketing your medical product in the Eurasian Economic Union's (EAEU) rapidly expanding pharmaceutical industry, Biomapas is the ideal partner for you. The EAEU is an exciting market for drug registration. Our specialists are eager to discuss the various paths for drug registration in the Eurasian Economic Union and provide guidance on aligning already registered medicines' dossiers with the new criteria. 

Authority Interaction & Scientific Advice

As the regulatory environment becomes more complicated, Biomapas' specialists assist our customers in navigating it. We assist you from the planning and implementation of early-stage research through approval and beyond. To help you get the most from Scientific Advice meetings, our experts can prepare questions that deliver the answers you need, interpret agency responses, and rehearse meeting scenarios.

Lifecycle Management

Experience in renewing and modifying pharmaceutical products and other aspects of medical product lifecycle management is essential to achieving corporate objectives. To help you reach them, we offer different solutions to our clients based on their portfolios ranging from small molecules to ATMP's and Medical Devices.

Regulatory Intelligence

With the help of Biomapas' Regulatory Intelligence services, you can create a viable drug development program, conduct efficient trials, and develop a sound commercialization plan. We combine our knowledge and expertise with publically accessible data and experience-based data sources to create a solid strategy that will save you time and money. Shortly, we facilitate you in making strategic decisions and gaining an edge in a competitive market.

Promotional Materials & Packaging Updates

Pharmaceutical firms are required to comply with health authority regulations on promotional materials and activities that they participate in or support with the intent of influencing the prescription and usage of a medicinal product. Therefore, all your promotional materials should comply with the international and national standards established by the European Union (EU) and local health authorities for marketing medicines.

13 + 6 =

Olga Bernardova

Olga Bernardova

Head of Global Regulatory Affairs

Olga Bernardova has over a decade of regulatory affairs experience. As a proven leader in regulatory affairs, Olga Bernardova has in-depth experience at regional and international level regulatory activities guidance and implementation.

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Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.

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Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.

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Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.