“The pharmaceutical industry is a key area for medical progress and the global economy.

The innovation-driven pharmaceutical industry has contributed significantly to improving patients’ lives and increasing life expectancy. Today, citizens can expect to live up to 30 years longer than they did a century ago.

Beyond playing a key role in medical progress through research, development and bringing to market new medicines that improve patients’ health and quality of life, the innovative pharmaceutical industry is a key sector of the global economy, being one of the best performing high-tech sectors in the world

As a healthcare and pharmaceutical consulting company, we are everywhere our customers are, providing them with the best consulting services in the medical and pharmaceutical fields”.

  Adriana COTEL, PhD
CEO and CoFounder HPSS

Our mission is to be part of the success our clients achieve, providing them with the best consulting services in the medical and pharmaceutical fields. Our client orientation, visionary management, high quality services and top notch professionalism are the values that guide our professional consultancy activities.

We want to make a difference on the healthcare market. That is why we share our expertise at industry seminars, speak at conferences and look for ways to encourage dialogue – with companies from the healthcare and pharmaceuticals industry, with competent authorities, with national and international organisations, with policymakers, public and with other stakeholders.

First-class service with a motivated team of experts who are the driving force behind our growth – and more importantly, behind our customers’ success. Our staff includes pharmacists, physicians, microbiologists, economists and as well as former employees of competent authorities, university teachers with insider knowledge and young university graduates with innovative ideas.

We support our clients with multidisciplinary experience when it comes to regulatory affairs, scientific and medical affairs, quality management in pharmaceutical consulting. Our staff specialists are committed to our clients’ projects worldwide, always keep the big picture in mind and help ensure that everything goes smoothly.

With offices in Bucharest-Romania, HPSS operates around the world and offer you the opportunity to enter into the European Union pharmaceutical market – as Romania is an European Union Member State.

Areas of practice

– Market Access

– Regulatory Affairs

– GxP Consulting

– Pharmacovigilance

– Communication and marketing

– Medical Devices

Regulatory Affairs from preparing the eCTD dossier to ……

The field of “regulatory affairs” encompasses all the work that is necessary to receive and maintain a marketing authorisation or registration for a human medicinal product. Authorisation dossiers are at the forefront of this regulatory process. HPSS’s regulatory affairs managers work on behalf of pharmaceutical companies to compile information about medicinal products and present it in the form the competent authorities require. With each signed contract, customers put their trust in our regulatory expertise in preparing and maintaining such files. On behalf of our clients, we compile all information on clinical trials, medical safety and efficacy studies, drug quality, analytical testing, approved use, pharmacovigilance and more into a common (electronic) technical document, also known as an eCTD dossier.

… and Marketing Authorisation …

Our regulatory affairs managers advise pharmaceutical companies on how they can launch human medicinal products without delays and keep them on the market throughout their life cycle. We evaluate existing documents/dossiers, point out options that make sense from a strategic and regulatory perspective and support scientific consultation with the appropriate competent authorities. We also manage marketing authorisation projects:

• National authorisation procedures (NP)

• Mutual recognition procedures (MRP)

• Decentralised procedures (DCP)

• Centralised procedures (CP)

to Renewal….

We stay active on our clients’ behalf, even after their medicinal products have received the marketing authorisation. Our drug regulatory affairs managers update existing dossiers to keep them in line with current legal requirements and take care of variations to the marketing authorisation when the change arises. We can also take on direct responsibility for human medicinal products depending on particular situation and your requirements, acting as empowered person for communication with competent authorities in the name of the marketing authorisation holder (MAH), qualified person for pharmacovigilance (QPPV), quality qualified person.

Market Access

HPSS helps companies develop a portfolio strategy that allows them to position themselves optimally in the pharmaceutical market. We play an active role in helping make companies’ workflows more efficient and transparent. The following elements make HPSS’s portfolio strategies stand out:

• Business plan assessment, strategy set-up

• Issuing opinions regarding necessary regulations/legislative changes

• Stakeholder mapping

• Competition assessment (prices, settlement, and Health Technology Assessment – HTA)

• Submission and approval of human medicines price files

• Advice for drawing up and submitting the HTA applications

• Access of human medicines to refund/reimbursement national lists

• Monitoring applications submitted with the competent authorities for authorisation

• Ensuring communication and representation between the company and the competent authorities

• Cost efficiency studies

• Monitoring current market access legislation and triggering legislative changes

• Specialized market access legal assistance

Pharmacovigilance and drug safety

When it comes to drug safety, HPSS is a reliable partner to the pharmaceutical industry. We take care of everything – from preparing the Periodic safety update reports (PSURs) to developing complete pharmacovigilance systems.

Pharmacovigilance services

Developing of a pharmacovigilance system and compiling the necessary risk management plans and Standard Operations Procedures (SOPs) can tie up capacities at pharmaceutical companies. The Summary of this Pharmacovigilance System Master File (Summary-PSMF) is a necessary requirement to gain a marketing authorisation. HPSS provides solutions to make pharmacovigilance safe, yet easier for companies. We help audit internal drug safety procedures, draft SOPs and can provide appropriate risk management plans and complete pharmacovigilance systems if needed.

GxP Consulting

HPSS provides quality management, quality control and quality assurance services. We provide advice on implementing good practice (or GxP) guidelines – and we ensure compliance. Pharmaceutical quality management system covers all aspects of a product’s life cycle, from development to patient use. Quality assurance measures, known as “good practice”, are in place for every step along the pharmaceutical way.

These include good manufacturing practice (GMP) guidelines, which were first published by the WHO in 1968 and have since been amended and expanded on several occasions. The EU GMP Guidelines outline the GMP rules applicable in the European Union. There are also similar EU guidelines for the distribution of medicinal products (good distribution practice, GDP) and drug safety monitoring (good pharmaco–vigliance practice, GVP). A company’s Qualified Person (QP), or its Qualified Person for PharmacoVigilance (QPPV) is responsible for ensuring compliance with GxP guidelines.

HPSS supports pharmaceutical companies and their QPs in efficiently integrating these standards into their own quality management systems, complying with GxP guide–lines and proving compliance to competent authorities during inspections. We develop complete GxP quality management systems and provide advice on quality assurance.

Excellence and Quality in GMP Audits Worldwide

HPSS organizes independent GMP, GDP, GVP audits worldwide. This ensures highest quality audits and a high level of independence and acceptance by competent authorities worldwide. We organize these audits in Europe, Vietnam, China, India, UAE, USA and further countries worldwide.

We guarantee the highest quality of audits.

• Audits performed by qualified European auditors

• Comprehensive audit reports

• Confidentiality and no conflict of interest guaranteed

• Evaluation of Corrective and Preventive Action (CAPA) Plans and issuance of CAPA declaration

• Acceptance by authorities worldwide

Regulatory services for medical devices: approval and Quality Management (QM) system

We are the professional contact for all questions that arise with regard to the market requirements, medical devices directives and especially the new EU regulations on medical devices.

Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD) pose challenges to manufacturers of medical devices and IVDs. Substance-based medical devices, such as lozenges, dermatological products or nasal sprays which have a physical effect, are assigned to a higher risk class under the Medical Devices Regulation (MDR). As a result, certification is necessary to ensure their continued marketability. We help manufacturers to effectively and efficiently meet the requirements of the Regulations on Medical Devices and IVDs.

As a healthcare and pharmaceutical service provider, we are where our clients are, all around the world.

Your advantages with HPSS:

• Time- and cost- savings

• High-quality and efficient support for your company

• Confidentiality and no conflict of interest guaranteed

• A new approach to launch excellence

Please contact us for an overview of all our company’s activities and for any planning activity.

Contact our international HPSS team:

office@hpss-consulting.com

HPSS Consulting Healthcare Provider Strategies & Solutions (hpss-consulting.com)