As qualified and experienced experts, we successfully support our clients in pharma consulting: in relation to regulatory affairs, pharmacovigilance, parallel distribution / parallel import and quality management.
Your specialist for pharma consulting
We approach our projects with head, heart and hand. That is what sets us apart.
Drawing on our many years of experience in the pharmaceutical industry, we work in a forward-looking and hands-on manner to provide our clients with the best possible service and immediate assistance. We work on your project with heart and passion, so that we can contribute to your success in a sustainable and targeted manner.
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Regulatory Affairs – Pharma Consulting
New submissions and support for marketing authorisations for pharmaceutical products, including eCTD creation, belong to the main activities of likeyourpharma. Accordingly, we successfully manage more than 200 marketing authorisations for various clients. Our Regulatory Affairs department covers all the work required for obtaining marketing authorisations for pharmaceutical products or its registrations and keeping it up to date. First and foremost, we apply for marketing authorisations under national and European law. This includes compilation/creation of the registration file in eCTD format. Once the application has been submitted, we handle the authorisation process until authorisation is granted.
We also provide you with post-authorisation support
Even after the successful granting of a marketing authorisation for a medicinal product, we continue to support our clients. For example, when changes occur during the life cycle of a medicinal product, we process and update the existing documentation, the registration file, and/or the informative texts and submit change notifications/variations. In addition, we can offer the responsibility for the medicinal product as an information officer according to § 74a AMG, depending on requirements.
Life-cycle Management – Pharma Consulting
The drafting and editing of CMC documents (CMC=Chemistry, Manufacturing, Control) incl. communication with suppliers, partners and competent authorities, as well as the coordination of the necessary activities, timely submission of change notifications/variations and updating and compiling product information texts (PIT) in accordance with § 10, 11, 11a of German Drug Law (AMG) as well as creating eCTD sequences (Lorenz Docubridge) belong to the daily activities of likeyourpharma. Furthermore, we take over the timely creation and submission of renewals, the monitoring of the sunset clause deadlines and PSUR deadlines as well as the reporting in the Xevmpd EMA database.
Pharmacovigilance – Pharma Consulting
As experienced experts in pharma consulting, we seek out cooperation with other service provider/cooperation partner in pharmacovigilance as needed to successfully undertake all activities, such as compiling PSUR (Periodic Safety Update Report), RMP (Risk Management Plan) or PSMF (Pharmacovigilance System Master File), as well as the establishment of complete pharmacovigilance systems.
In addition, we monitor the safety of the clients’ authorised medicinal products together with cooperation partner.
Iif required,we assume responsibility for the pharmaceutical products as Graduated Plan Officer pursuant to § 63b of German Drug Law (AMG) and as QPPV (Qualified Person for Pharmacovigilance).
Parallel Import – Pharma Consulting
Pharmaceutical companies/manufacturers market many of their medicinal products in Germany as well as in other Member States of the European Union (EU) or the European Economic Area (EEA). For each of these products they hold a separate national marketing authorisation in the respective Member State. A ’parallel imported medicinal product’ is bought by a third company independent of the original marketing authorisation holder (MAH) or manufacturer in another Member State of the EU or EEA and is imported into Germany to be marketed here in parallel to the product marketed by the original pharmaceutical company.
No parallel imported medicinal product may be imported or placed on the German market unless the company has received a corresponding licence by the national competent authority for human medicinal products – i.e., either the BfArM (Federal Institute for Drugs and Medical Devices) or the PEI (Paul-Ehrlich-Institut). Parallel import is not possible if the medicinal product is authorised and marketed outside the EU or EEA.
likeyourpharma takes over the compiling of documentation for parallel import authorisation applications in consultation with the client.
Parallel Distribution – Pharma Consulting
On 20 May 2004, notifications of parallel distribution of centrally authorised medicinal products became mandatory throughout the European Union, in accordance with Article 57(1)(o) of Regulation (EC) No 726/2004. Since that date, all medicinal products on the market in the EU distributed in parallel have to comply with the requirements of the EMA notification procedure for parallel distribution. Similarly, the parallel distribution of centrally authorised medicinal products on the market for which a notification has not been applied for must comply with those requirements.
We take over responsibility for the notification and support of the parallel distribution on the online “IRIS” platform set up by the EMA since February 11, 2019. Once notification for parallel distribution has been granted, likeyourpharma continues to support the life-cycle management and submits the required safety or annual updates.
Quality Management – Pharma Consulting
Besides establishing a quality management system (QM) according to the EU-GDP Guideline for applying for a wholesale license pursuant to § 52a German Drug Law (AMG) or for applying for manufacturing license pursuant to § 13 German Drug Law (AMG), likeyourpharma is happy to support you with auditing quality management systems and GAP analyses, with conducting self-inspections, with supervising inspections by authorities, with reviewing manufacturing and test instructions for conformity with marketing authorisation, with preparing product quality reviews (PQR) and with managing GxP audits at finished product manufacturers incl. drawing up audit reports and following up CAPA reports.
Your contact persons
We rely on a cordial and trusting cooperation in order to provide you with reliable, fast and sustainable solutions.
Nadine Braune
Our clients benefit daily from Nadine Braune’s acquired knowledge from over 20 years of experience.
Björn Braune
Björn Braune is your responsible contact person for finance, administration and human resources.
We thank you in advance for
a trusting cooperation. a successful project. a focused partnership.
Would you like to become a member of our Pharma Consulting team?
Shape our growth with your expertise and personality. In short: we look forward to receiving your detailed application documents, stating your earliest possible starting date and salary expectations.
Pharmacovigilance Manager/Graduated Plan Officer/QPPV (m/w/d)
We are looking for a dynamic, enthusiastic and solutions-focussed personality who demonstrates initiative and flexibility and would like to prove their talent. Your range of duties:
- Responsibility as Graduated Plan Officer pursuant to Sec. 63 A German Medicines Act (AMG)
- Accurate recording and tracking of known adverse effects and pharmaceutical risks in line with regulatory requirements.
- Timely submission of documentation on adverse effects
- Ensuring PV systems are in place and drawing up and updating SOPs
- Participation in inspections and audits
- Processing of reports on potential pharmaceutical risks and their assessment
- Signal detection and case management
- Continuous updating of the benefit-risk assessment of the pharmaceutical products
- Coordination and documentation of pharmaceutical safety measures within the company and authorities
- Entering incoming reports into the pharmacovigilance database and monitoring notification obligations
- Preparation and evaluation of safety reports (e.g. PSUR, RMP)
- Telephone-based availability (for medical enquiries and reports of adverse effects)
- Responsibility for pharmacovigilance, ranging from literature research to processing adverse reaction reports, signal detection and compiling periodic safety reports and profiles, to maintaining the corresponding lists and databases.
- Direct communication with doctors, pharmacists and patients, with the group headquarters as well as its overseas branches
and with domestic and overseas authorities and business partners
Regulatory Affairs Manager (m/w/d)
We are looking for a dynamic, enthusiastic and solutions-focussed personality who demonstrates initiative and flexibility and would like to prove their talent. Your range of duties:
● Life-cycle management with preparation and implementation of EU and non-EU variations incl. regulatory evaluation of change control applications
● Updating of relevant authorisations databases
● Timely sourcing and review of authorisation/registration documents
● Drafting and compilation of CMC documents (esp. Module 2.3 and 3)
● eCTD compilation
● New submissions and support for national and DC procedures
● Based on agreement, information officer pursuant to Sec. 74a German Medicines Act (AMG)
