Services



Project management is the process of planning, organizing, and managing tasks and resources to accomplish a well defined objective, usually within constraints on time, resources, or cost.

Herman-Medical can offer:
  • Management of development projects from initiation through to license approval,
  • Project Plan preparation with Critical Path, Milestones, Resource and Budget Allocation,
  • Set up and support of Project Management systems within a company
  • Abridged applications in the EU are applications made under Directive 2001/83/EC Article 10(1) or 10(c), as amended, whilst bibliographic applications are covered by Article 10(a).

    Our area of expertise is the preparation and submission of applications in accordance with the following paragraphs:

  • 10(1) – generic application. Previously known as an "essentially similar" application, this type of application is when the applicant cross refers to the dossier of the originator product. The conditions to be met include, but are not limited to, the product in question having the same qualitative and quantitative composition in terms of active ingredient, the same pharmaceutical form and proven in vivo bioequivalence.
  • The originator product must also be on the market in at least one member state and have been authorized for six or ten years, depending on the country, before the application can be made. However, Directive 2004/27/EC amending Directive 2001/83/EC states that all countries enforce an 8 year data exclusivity rule with respect to submissions and 10 years with respect to marketing for all drug products containing a drug substance submitted for authorization after the implementation of Directive 2004/27/EC (deadline for transposition 30/10/2005).
  • 10(a) – well established use applications. This type of application is also known as a "bibliographic" application as the applicant prepares a dossier on the product based on the literature available in the public domain. The drug product concerned needs to have been on the market for at least 10 years. This type of application is especially important to the newer Member States as it allows them to keep their current generic products on the market where no reference product exists.
  • 10(b) – fixed combination applications. This is an application for a drug product which combines more than one known drug substance in one pharmaceutical form such as a tablet or capsule. Results of clinical and pre-clinical tests will be required for this application and consequently it is a "full" application with its own corresponding period of data exclusivity.
  • 10(c) – informed consent applications. This is where the holder of the originator marketing authorization (or "license") allows a second applicant to cross refer to their original dossier. This means that the second applicant does not have to carry out any clinical, toxicological or pharmacological tests of their own.
  • 10(3) – "hybrid" applications. Hybrid applications are where the drug product does not necessarily fall within the definition of a "generic" medicinal product but where only bridging studies are provided to supplement the abridged nature of the application.
  • 10(4) – "bio-similar" applications. This is where there is an application for a biological medicinal product where the reference medicinal product does not meet the requirements of a "generic" medicinal product because of differences in raw materials or in the manufacturing process.

  • Applications for Marketing Authorizations for human medicinal products and traditional herbal medicinal products will be prepared using the new Common Technical Document (CTD) format. This format is common to the EU, US (not mandatory) and Japan. It is also acceptable in many other countries such as Switzerland, Canada and New Zealand.

    Preparation of Clinical Summaries and Overviews, Non-Clinical Summaries and Overviews and Quality Summaries and Overviews (formerly Clinical, Pre-Clinical and Pharmaceutical Expert Reports) Comparisons of the Summary of Product Characteristics (SmPCs) of the originator products in target markets to identify all areas of potential contention between the Health Authorities in the markets of choice.

    Advice on how to meet individual country requirements to ensure a rapid and successful assessment of your dossier.

    Abridged applications for human medicinal products in the EU are applications made under Article 10(1) of Directive 2001/83/EC, as amended.

    A national application is made when your company wishes only to market in one country in the EU. Therefore, no Mutual Recognition Procedure or Decentralized Procedure is planned.

  • Herman-Medical is well versed in the preparation and submission of applications for national marketing authorizations, or licenses, in all EU states. We would act as liaison to the Health Authority on your behalf to answer any queries arising from the application.
  • Herman-Medical would also liaise with the Health Authority on your behalf before the application is submitted should there be any need to seek the Health Authority's advice prior to submission. (Regulatory Strategy).
  • Abridged applications for human medicinal products in the EU are applications made under Article 10(1) of Directive 2001/83/EC, as amended. Mutual Recognition Procedures can be carried out on products approved under Article 10(1), using Article 28(2).

    A Mutual Recognition Procedure (MRP) is used when your company wishes to market the same medicinal product in more than one country in the EU and where you already have a license in at least one EU MS.

    This MRP may be initiated either by the Health Authority (HA) or by the Applicant.

  • A HA may start an MRP when an application for the same product is submitted in more than one EU member state at the same time. In this case, one of the Member States suspends assessment of the application and waits for the other Member State to complete assessment and issue a license before recognizing the application.
  • An applicant may instigate an MRP by notifying the Health Authority into which the first National Application is made (Reference Member State or RMS) that they intend to submit the approved dossier into a number of other Member States (Concerned Member States or CMSs) following license approval.

  • Herman-Medical has a wealth of experience in preparing and submitting dossiers using the MRP system.

    Herman-Medical can manage all aspects of the procedure independently or in liaison with your own Regulatory Affairs department.

    Abridged applications for human medicinal products in the EU are applications made under Article 10(1) of Directive 2001/83/EC, as amended. Mutual Recognition Procedures can be carried out on products approved under Article 10(1), using Article 28(2).

    A Mutual Recognition Procedure (MRP) is used when your company wishes to market the same medicinal product in more than one country in the EU and where you already have a license in at least one EU MS.

    This MRP may be initiated either by the Health Authority (HA) or by the Applicant.

  • A HA may start an MRP when an application for the same product is submitted in more than one EU member state at the same time. In this case, one of the Member States suspends assessment of the application and waits for the other Member State to complete assessment and issue a license before recognizing the application.
  • An applicant may instigate an MRP by notifying the Health Authority into which the first National Application is made (Reference Member State or RMS) that they intend to submit the approved dossier into a number of other Member States (Concerned Member States or CMSs) following license approval.

  • Herman-Medical has a wealth of experience in preparing and submitting dossiers using the MRP system.

    Herman-Medical can manage all aspects of the procedure independently or in liaison with your own Regulatory Affairs department.

    Variations are any change to the licensed details following approval in any Member State.

    The new variations regulation for human and veterinary medicinal products Regulation (EC) 1084/2003, are three main types of variations detailed in this regulation:

  • Type IA variations – these "minor" variations generally refer to changes in the name/address of the Marketing Authorization Holder or a change to the manufacturer' name and address, a minor change to the batch size, submission of a Certificate of Suitability for the drug substance, amongst others.
  • Type IB variations – these "minor" variations generally refer to a change in the name of the product, minor changes to the method of manufacture for the drug substance or drug product, swapping one excipient for a comparable excipient, changes to batch size, change in shelf life of the drug product, etc.
  • Type II variations – these "major" variations are any variations that are deemed to be outside the scope of the variations listed as Type I.

  • Herman-Medical can prepare variations to your license for you. We can also give you advice on what supporting data you would need for a particular variation, review the data as it becomes available and answer any questions that the Health Authority may have on your application.

    Marketing authorizations/ licenses for human and veterinary medicinal products will have unlimited validity. However, the marketing authorization must be renewed once within five years of approval and must be placed on the market within three years of approval.

    A further renewal may be necessary on pharmacovigilance grounds.

    As part of the renewal procedure, a Periodic Safety Update Report (PSUR) must be submitted. This provides the Health Authority with information on any adverse events to the product over that period. (Pharmacovigilance).

    Herman-Medical can prepare renewal applications and accompanying PSURs on request.

    Herman-Medical can also review your data in preparation for a renewal application.

    The European Directorate for the Quality of Medicines (EQDM) is the body responsible for granting CEPs to active pharmaceutical ingredients which are monographed in the European Pharmacopoeia.

    An active pharmaceutical ingredient manufacturer may apply to the EQDM for a CEP for any chemical entity which has a monograph in the European Pharmacopoeia.

    The EQDM also issues CEPs for any product with a possible associated TSE risk.

    Herman-Medical can provide advice on how to prepare your submission for a Certificate of Suitability for your drug substance.

    Herman-Medical can review the data that you are planning to submit to obtain a Certificate of Suitability.

    Herman-Medical can prepare your submission for a Certificate of Suitability.

    Two medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailability after administration in the same molar dose is similar to such a degree that their effects, with respect to both efficacy and safety, are the same.

    Bioequivalence studies (also known as bio-studies) are a necessary part of proving essential similarity for generic applications. A bio-study demonstrates if slight differences in formulation, method of manufacture or source of active ingredients have an impact on the rate and extent of absorption.

    Herman-Medical has extensive experience in the field of bio-study management. We can:

  • Source a Contract Research Organization (CRO) to carry out either or both the clinical and analytical aspects of a bio-study,
  • Carry out pre-study audits of the CRO,
  • Provide advice on and review bio-study designs,
  • Monitor studies to ensure Good Clinical Practice (GCP) compliance,
  • Review of final reports.

  • All of above are carried out in accordance with current GCP as per the ICH guidelines.

    As regulatory affairs consultants, one of prime areas of expertise is in regulatory submission strategy planning.

    To market in more than one territory in the EU, a pharmaceutical company must use either the centralized or decentralized procedures (either MRP or DCP) to register a product.

    Part of the process is harmonizing the generic product Summary of Product Characteristics (SmPC) across all territories, even though the originator SmPC may not be harmonized.

    SmPC Comparisons

    It is a vital part of any company's Market planning to highlight all potential areas of contention between Concerned Member States (CMSs). This is typically on issues such as indications, contraindications, dose and posology – all of which are in the SmPC.

    Herman-Medical can liaise with Health Authorities prior to submission on SmPCs, quality issues, bio-study strategy, etc.

    Herman-Medical can help your company to devise the best route for product approval in all markets in time for patent expiry.

    Herman-Medical has been working closely with generic pharmaceutical companies in the new Member States and with current accession countries to bring their documentation and systems up to standard for entry into the EU.

    Marketing Authorisation Holders (MAHs) have a legal obligation, under Directive 2001/83/EC, as amended, to set up and maintain a system for Pharmacovigilance. This involves collection, collation and evaluation of information about suspected Adverse Drug Reactions (ADRs) to their medicinal products under normal conditions of use in the market place. This requirement must be met by generic pharmaceutical MAHs as well as the holders of the original licenses.

    Herman-Medical can provide advises on setting up and maintaining workable pharmacovigilance system.

    Additionally, we can aid you in the preparation and review of Periodic Safety Update Reports (PSURs).

    The purpose of regulatory compliance is to provide a controlled link between documentation submitted to regulatory authorities in support of marketing authorizations and documentation that is utilized by the company's Operations/Production and QA departments.

    A regulatory compliance system is a formal, documented system which will ensure that the product is always manufactured and released in line with the Good Manufacturing Practices (GMP), technical agreements and currently licensed particulars.

    As part of the regulatory compliance system a number of Standard Operating Procedures (SOPs) should be introduced which will set up and manage the documented system. Whilst Quality Assurance (QA) is the department with responsibility for controlling the SOPs, Regulatory Affairs also has certain responsibilities with respect to SOPs. These include, but are not limited to, demonstrating compliance to GCP guidelines, pharmacovigilance and documentation control (in particular change control procedures).

    Herman-Medical can provide expert advice on the set-up of a Compliance System in your company. Moreover, we can support your new team with the Change Control Procedures that need to be implemented as part of a Compliance System.

    Change Control Procedures allow your company to measure the cost of a change vs. the potential savings to decide if you really need that change. It is also quality assurance driven, and any change which is GMP related must be approved through the change control procedure before being implemented.

    It is also the responsibility of a regulatory compliance department to make certain that the regulatory compliance system in place measures the companies’ adherence to the current marketing authorizations. This can be achieved by introducing a schedule of regulatory compliance audits to monitor the system.

    Herman-Medical can prepare the necessary SOPs to manage a compliance system including the introduction of compliance audits to monitor the system

    Herman-Medical can prepare or review job descriptions for personnel currently involved in documentation control

    Herman-Medical can provide the necessary support to the compliance team by carrying out external system audits on a regular basis.

    Herman-Medical can provide updates on all regulatory changes and developments in the EU that may impact on your company in relation to compliance

    In any pharmaceutical company it is the responsibility of the Regulatory Affairs department to ensure that your product has approved Marketing Authorizations for each product in each territory on the target date. Due to the complexity of the EU system for Marketing Authorizations applications, it can take years of practice to get your staff to a level of competency to achieve this goal every time.

    Herman-Medical can provide your company with specialized Regulatory Affairs training, tailored to your specific needs. We specialize in generic pharmaceutical medicinal products and their registration and this involves an in-depth understanding of the commercial and marketing requirements of generic pharmaceutical companies.

    Regulatory Affairs training is not just for your Regulatory Affairs team. Each company is a compact unit made up of interdependent departments. The success of any company rests on knowing its target markets and getting a quality product to these markets on time in a cost effective manner.

    Each department in a company is dependent on each other department to provide the expertise and experience necessary to achieve the company’s goals.

    However, this cannot be done without the input, data and support of the following departments and people:

  • Patents
  • Research and Development
  • Analytical
  • Quality Assurance
  • Quality Control
  • Stability
  • Production
  • Logistics
  • Sales and Marketing
  • Administration

  • Herman-Medical can provide Regulatory Affairs Overview Training to all interested parties. This will provide an insight into what Regulatory Affairs do, why they do it, how they do it and what they need from other departments to make it work. Also included is comprehensive, specialized training in all aspects of the EU legislation and in the MRP/DCP/CTD system for registering generic drugs in the EU, which is our speciality.

    Training includes:

  • Full text notes including suggested wording for certain sections of the dossier
  • Case studies tailored to your level of knowledge
  • All relevant and current guidelines for each section
  • According to EU Directive 2004/24/EC, traditional herbal medicinal products are defined as:

    (a) products which have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;

    (b) products that are exclusively for administration in accordance with a specified strength and posology;

    (c) products that are an oral, external and/or inhalation preparation;

    (d) products that have bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community;

    (e) products where the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.

    These herbal medicines are now required to meet safety, quality and efficacy criteria in a similar manner to any other licensed medicines as laid out in the new Traditional Herbal Medicinal Products Directive (2004/24/EC), which amends the Community code relating to medicinal products for human use (Directive 2001/83/EC).

    The new scheme will require traditional herbal medicines to meet specific and appropriate standards of safety and quality. This new EU system will not require full clinical trials to prove safety but manufacturers will have to prove that their products have been in medical use for at least 30 years, including 15 years in the EU.

    This latest piece of European legislation introduces a simplified registration procedure for all traditional herbal medicinal products.

    As laid out in the Directive the following information will be required:

  • Application form
  • Labeling/mock-up label and patient information leaflet (PIL)
  • Summary of Product Characteristics (SmPC)
  • Information about the experts providing evidence on safety and traditional use.
  • A technical/quality dossier covering the quality of herbal ingredients and the finished herbal product. This quality dossier will need to include details of all the necessary physico-chemical, biological and microbiological tests.
  • The application will also need to be accompanied by a bibliographic review of safety data together with an expert report.
  • The application will need to be accompanied by bibliographic or expert evidence that the product has been in medicinal use throughout a period of 30 years.

  • Herman-Medical is in a unique position to be able to advise companies on the documentation needed and the legislation to be followed.

    We can prepare and/or review your application either to the Romanian Competent Authority or any other European Member State Competent Authority.

    We can advise you on the steps that your company needs to take from a manufacturing point of view to comply with any EU Directives, Regulations and Notes for Guidance.

    We can write or review your Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).

  • CE Marking
  • Product classification
  • Preparation of technical files
  • Risk assessments
  • Quality audits

  • Herman-Medical offers wide-ranging consultancy services relating to medical devices and in vitro diagnostics as well as medicinal products. Our team of highly qualified experts includes pharmacists, biologists, chemists and medical practitioners. We can provide advice on product development, preclinical and clinical research, regulatory affairs and quality assurance as well as post-marketing aspects such as vigilance.

    Herman-Medical will be pleased to assist with planning R&D programs for novel products; designing suitable studies to meet regulatory requirements and achieving timely approvals in the countries of interest. GMP, QSR and ISO 9000 audits of companies, their suppliers and subcontractors can be undertaken by our IRCA certificated lead auditor ensuring that the appropriate standards of quality are met.

    CE Marking

    Medical device registration in the European Union is now harmonized with four directives in force:

  • Medical Devices Directive
  • Active Implantable Medical Devices Directive
  • In Vitro Diagnostic Medical Devices Directive
  • Electromagnetic Compatibility Directive

  • In principle, products bearing the CE mark can be freely marketed in all member states without further control. Thus the importance of achieving timely CE marking cannot be over-emphasized.

    First of all we will classify your product to determine which legislation applies and advise on the optimum route to the market. We can assist with technical files, essential requirement documentation, risk assessments, preparations for conformity assessment and, where applicable, recommend which of the many Notified Bodies best suits the situation, acting, if required, as the point of liaison.

    Our multidisciplinary team can provide detailed assessment reports of all the technical documentation against the relevant requirements. Thus assembly of all the necessary documentation can be assured to a standard aimed to achieve a successful regulatory approval the first time around.

    Our team is available to advise on regulatory, scientific and quality matters, including ISO 9000 and related standards. All types of products are handled, from active and non-active devices, including sterile and electro-medical products to in vitro diagnostics as well as drug-device combinations and borderline products.

    The Drug-Device Borderline

    Regulatory requirements for products falling on the drug-device borderline vary enormously from nation to nation and it is not always easy to determine whether a product falls within drug or device legislation or is unregulated. Thus specialized knowledge is invaluable in reaching a global marketing strategy.

    Herman-Medical are experienced with both sides of the drug-device borderline and can therefore help clarify the specific regulatory issues that would apply in a particular case as well as achieve successful approvals in the territories of interest.

    In the case of drug-device combinations, we have assisted many clients in the development of their products; planning the studies required for multinational launches and in establishing satisfactory quality systems. We have considerable experience with the registration of such products with both drug and device regulatory authorities.