Cookie-Settings

We use technically necessary cookies for the operation of the website. Other cookies are only set with your consent. We use these to statistically analyse the use of the website (location, time, end device, referrer URL). We also share information about the use of the website with our provider Google LLC. We have also integrated videos into our website via the provider Vimeo, a video hosting platform. The service provider is Vimeo Inc. Both providers may combine this information with other data. Your data may also be transferred to the USA. The USA (and other non-EEA countries) do not offer a level of data protection comparable to the EU; for example, government agencies can access data without any reason. However, both Google LLC. and Vimeo Inc. are committed to data protection-compliant processing with the EU standard contractual clauses.
You can revoke your consent to cookies and data transfer at any time with effect for the future. You can find more information in our privacy policy.

These cookies help making a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.

These cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously. With this information we can constantly improve the experience we offer on our website.

These cookies are used to track visitors across websites. The intention is to display ads that are relevant and engaging for the individual user and thereby more valuable for publishers and third party advertisers.

DE
  • Home
  • About medac
  • Information for patients
  • Healthcare professionals
  • Products
  • Career opportunities
  • Media
  • medac’s Product Development

    “We will improve our patients’ quality of life with therapies that are of the highest quality yet affordable and always available; this is our responsibility.”

    In line with our company’s vision, our Product Development develops new medicinal products with additional benefits to patients in specific niche indications with high therapeutic needs -  also as a reliable development partner in cooperation with you.

    In this, we always focus on our customers and are open to new technologies. We continuously strive to optimise our processes, thereby increasing the agility and efficiency of our opportunities-based approach. This allows us to constantly improve our products and create added value for the good of our patients. Our focus is on indications in the therapeutic areas of oncology, haematology, urology and autoimmune diseases.

    As a medium-sized pharmaceutical company we are proud of the global focus of our Product Development which offers a wide range of knowledge and expertise.

    Our highly qualified scientists contribute their know-how early on during the search for new product opportunities and design innovative, regulation-compliant development plans, which are then implemented efficiently and with an eye on the goal.

    Find more information on our expertise in the development of new products and ways of cooperating with us as your development partner here.

    With our experience we can support you as a reliable cooperation partner to find the right solution for your unmet market needs.

    The road to an authorised, marketable product - our expertise covers all steps

    Our Product Development has a modular set-up, which means that we are comfortable working in various cooperation models with small start-ups as well as larger biotech and pharmaceutical companies. From completing the last steps of a marketing authorisation procedure to full product development from start to finish ‑ we can do it all. Our partners appreciate our commitment, the way we comprehensively contribute our expertise and experience and, not least, that cooperation with us is based on mutual trust and respect.

    Our spectrum, our expertise and know-how enable us to successfully carry out our own developments or, within the framework of a cooperation model, to contribute to finding the optimal solution for your unmet market needs for the benefit of patients.

    • Goal-oriented due diligences and gap analyses
    • Design of comprehensive, milestone-triggered, cost-efficient product development plans
    • Established network of key opinion leaders, academia, research-oriented non-profit organisations, experts in their fields and patient advocacy groups
    • Business cases, regulatory, market access and sales strategy planning

    In pharmaceutical development, 20 dedicated scientists work in a broad interdisciplinary field. Due to the existing expertise, innovative product developments can be realized effectively and efficiently - with the focus on the benefit for the patients. Even complex developments such as Drug-Device-Combinations (DDC) or Advanced Therapy Medicinal Products (ATMP) are successfully implemented. All regulatory requirements are observed and modern development methods are applied. The following list gives an overview of the field of activity of medac's Pharmaceutical Development.

    • ATM, stem-cell therapeutics
      • Clean-room production
      • Cell culture & banking
      • Bioanalytics
      • Comparability testing
      • Potency testing
    • Small molecule API
      • Process development
      • Scale-up
      • High potency API
      • Analytical methods
      • Formulations
      • Application forms (injectables, lyophilisates, tablets, etc.)
    • Drug Device Combinations / combination products
      • DIN ISO conformity
      • Human Factors Engineering
      • Full documentation for notified body opinions
    • Packaging and connectors
      • Primary & secondary packaging
    • Connector development
      • Selection and validation
      • Extractables & leachables
      • CCIT testing
      • Human Factors Engineering
      • Environmentally friendly
    • Biotechnology, biosimilars, biologics
      • Biotechnology process development
      • Recombinant proteins
      • Microorganisms
      • Fermentation production
    • CDMO Business
      • QbD design process development
      • Lab scale
      • Pilot scale
      • GMP conformity
      • Production scale
      • Qualification, validation
      • Tech transfer
    • Originals, generics, biologics, IMP, EU
      • Development for different regulatory pathways and guidelines
      • CTD module 3 creation
      • Input for IMPD and IB documents
    • Development of innovative drug products (process, validation, analytics, tech transfer)
    • Clinical trial supply
    • Human Factors Engineering and usability optimisation
    • Professional expertise in pharmacology and toxicology
    • Experienced in the design of state-of-the-art non-clinical development programmes
    • Comprehensive knowledge in the design, implementation, conduct, analysis, interpretation and reporting of in-vitro and in-vivo studies regarding pharmacology, pharmacokinetics/ADME and toxicology using a set of qualified laboratories and CROs, and a network of leading experts in non-clinical development
    • Scientific input and writing of non-clinical regulatory documents (e.g. briefing documents, DSUR, PSUR, PIP, IMPD, IB, CTD modules)
    • Design of non-clinical development programmes
    • Execution of studies in collaboration with qualified service providers
    • Interpretation of results and writing of non-clinical sections of regulatory documents

    Clinical Development consists of a multidisciplinary team of over 45 scientists with impressive expertise in the successful design and implementation of targeted, cost- and time-efficient, state-of-the-art, milestone-driven, globally-focused clinical development programs.

    Clinical Science

    • Broad experience in relevant indications, global development strategies and regulatory guidelines & legal requirements
    • Efficient evaluation of new product opportunities and gap analyses
    • Established network of key opinion leaders, academia, research-oriented non-profit organisations, experts in their fields and patient advocacy groups
    • Design of targeted, patient-centric clinical development programmes for new products and life-cycle activities (label extensions & bridging to additional territories)
    • Extensive experience in dealing with regulatory authorities and HTA bodies
    • Understanding of priorities
    • Comprehensive expertise in medical oversight
    • Efficient regulatory and scientific medical writing
    • Preparation and maintenance of all regulatory clinical documents to obtain/maintain marketing authorisations across the world 

    Clinical Research

    • GCP-compliant implementation and execution of global clinical trials from early phase to late phase; this includes the entire range of clinical pharmacology studies, exploratory & confirmatory efficacy and safety trials as well as phase IV research and Real World Data collection 
    • Broad expertise in professional interaction with regulatory bodies and ethics committees
    • Goal-oriented feasibility assessments
    • Established network with a set of qualified CROs and service providers to ensure GCP-compliance at all stages of development
    • Efficient outsourcing and robust oversight strategies

    Biostatistics

    • Comprehensive expertise in the methodological repertoire for entire clinical development programmes
    • Methodological support in defining objective Go-/No-Go decision rules for milestone-triggered development strategies
    • Broad senior expertise in statistical design, execution, analysing and reporting of clinical trials - from early to late phase
    • Modelling & Simulation for human pharmacology studies
    • Innovative & efficient design development such as adaptive trials and seamless phase II/III studies
    • Special knowledge of methods for rare diseases
    • Real-World Evidence generation

    Statistical Programming

    • Programming in SAS and R® within a validated computing environment
    • Member of CDISC® and full CDISC (SDTM, AdAM) compliant processes

    Clinical Data Management

    • Senior expertise in current clinical data management methodology
    • End-to-end clinical data management process
    • CRF creation from protocol
    • Data management consulting in protocol writing
    • CDISC compliance expertise (CDASH, ODM, SDTM)
    • eCRF standards and corporate CRF library

    eClinical Systems

    • Development, validation and deployment of software and systems in the GCP-relevant environment
    • Development and maintenance
    • Internal, validated tools for planning and documenting the monitoring of clinical trials
    • electronic Trial Master File
    • Quality oversight by planning and conducting audits for
      • Clinical trials
      • Internal systems and processes
      • Qualification and re-qualification of vendors and consultants
    • Consultancy with regard to GCP-specific issues
    • Preparation of and support during regulatory inspections
    • Patent search, watch and analysis
    • Development, protection and commercialisation of IP
    • IP strategy and risk mitigation
    • Global regulatory strategies before and after approval, including strategy for the entire global life cycle
    • Extensive activities prior to application for global regulatory approval(s):
      • Involvement in preparation of IMPD
      • Scientific advice process
      • Data protection strategies
      • PIP management
    • Management of the global marketing authorization dossier(s):
      • Preparation and updating of CTD modules 2.3 and 3, including connected data and document management
      • Preparation, review and compilation of regulatory dossiers for submission to global regulatory authorities (CTD modules 1-5)
    • Global regulatory affairs:
      • Regulatory submissions (e.g. CP, DCP/MRP, national submissions) including complete process management
      • Strategic management in responding to regulatory questions
    • Global Life-Cycle Management:
      • All post-approval activities (e.g., amendments, renewals, submission of periodic safety reports)
      • Ensuring compliance with all regulatory requirements (e.g. MDR, ICH-Q3D)
    • Submission of eCTDs:
      • Compilation, publishing/sending, e-submission management and life cycle activities.
    • Preparation of GxP-compliant translations in all official European languages
    • Labelling:
      • Labelling management
      • Maintenance of product information texts taking into account current QRD templates
    • Continuous maintenance of worldwide contacts with authorities (directly and via partners)

    We ensure continuous monitoring of the benefit-risk profile before and after approval.

    • Supervision of all safety-relevant aspects in interventional studies (Safety Oversight, SAE Management, Ongoing Safety Evaluation, collaboration in the preparation of study documents such as Clinical Trial Report, Investigator Brochure, Case Report Form, Informed Consent Form).
    • Evaluation and processing of global adverse event reports always according to current guidelines (MedDRA, E2B(R3))
    • Preparation of periodic safety reports (DSUR, PSUR/PBRER, Addendum to Clinical Overview)
    • Preparation and updating of safety-relevant passages in the technical information and directions for use (labeling)
    • Management of the global Company Core Data Sheet
    • Review and evaluation of global technical literature
    • Creation of risk management plans as well as creation and implementation of educational material and other risk minimizing measures
    • Continuous monitoring of the risk profile (signal management)
    • global monitoring of PV commitments in cooperation with our worldwide partners
    • comprehensive PV quality system and extensive inspection experience

    A continuously attractive product portfolio. How do we do it?

    We always have an eye on global market changes and look forward to facing new challenges. Our patients are at the heart of what we do, and with our many years of experience and expertise medac is ready for the future and the competition.

    Are you interested in becoming a member of this successful team? Then apply with us. 

    We would love to have you, as future colleague in one of our teams or as our development partner on the path to new, highly potent medicinal products. Let us expand our horizons - together.

    Your Contact
    medac GmbH
    Head Office
    Theaterstraße 6 22880 Wedel Germany
    Nach oben