medac’s Product Development

• 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

The Pharmaceutical Research and Development division employs 20 passionate scientists working across a broad interdisciplinary field. Thanks to the comprehensive expertise at hand, innovative product developments can be realised effectively and efficiently – with a focus on the benefit for patients. Complex developments such as drug-device combinations (DDC) or Advanced Therapy Medicinal Products (ATMP) are likewise achieved with a great deal of success. In doing so, all regulatory requirements are taken into account and modern development methods applied. The following list provides an overview of the Pharmaceutical Research and Development department’s area of activity at medac:

• ATM, stem-cell therapeutics
  • Clean-room production
  • Cell culture & banking
  • Bioanalytics
  • Comparability testing
  • Potency testing

• Small molecule API
  • Process development
  • Scale-up
  • High potency APIs
  • 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
  • Environmental awareness and sustainability

• Biotechnology, biosimilars, biologics
  • Biotechnology process development
  • Recombinant proteins
  • Microorganisms
  • Fermentation production

• CDMO Business
  • Development of the QbD process
  • Lab scale
  • Pilot scale
  • GMP conformity
  • Production scale
  • Qualification, validation
  • Tech transfer

• Originals, generics, biologics, IMP, EU
  • Development for different regulatory strategies 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

Clinical Development consists of a multi-disciplinary team of over 45 scientists with impressive expertise in the successful design and implementation of target-oriented, cost- and time-efficient, state-of-the-art, milestone-driven clinical development programmes that have a global focus.

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)
• Generation of real-world evidence
• Extensive experience in engaging with regulatory authorities and HTA committees
• 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 performance 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
• Extensive experience in the professional collaboration 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 and reliable outsourcing and oversight strategies

Biostatistics

• Comprehensive expertise in the statistical ranges of methods for entire clinical development programmes
• Methodological support in defining objective Go-/No-Go decision rules for milestone-triggered development strategies
• Many years of expertise in the statistical design, performance, evaluation and reporting of clinical trials – from early to late phase
• Pharmacological and pharmacodynamic modelling and simulation
• Innovative and efficient design development, such as adaptive study designs with complex hypothesis systems
• Special knowledge of methods for rare diseases and paediatrics
• Meta-analyses
• Indirect comparisons and generation of real-world evidence

Statistical Programming

• Programming in SAS and R^® within a validated computing environment
• Implementation of CDISC^® and entirely CDISC-compliant processes (SDTM, AdAM)

Clinical Data Management

• Many years of expertise in clinical data management methodology
• End-to-end clinical data management
• Data management consultation for the preparation of study records
• CRF creation from record
• CDISC compliance expertise (CDASH, ODM, SDTM)
• eCRF standards and corporate CRF library

eClinical Systems

• Development, validation and operation of software and systems in the GCP-relevant environment
• Development and maintenance
• In-house, validated tools for planning and documenting the oversight of clinical trials
• eTMF

• Quality oversight by planning and conducting audits for
  • Clinical trials
  • Internal systems and processes
  • Qualification and re-qualification of contract companies and external consultants
• Consultation 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

• Pre- and post-approval global regulatory strategies, incl. complete global life cycle strategy
• Extensive activities prior to submitting global marketing authorisation application(s):
  • Involvement in preparing the IMPD
  • Scientific advice procedures
  • Data protection strategies
  • PIP management
• Management of the global marketing authorisation dossier:
  • Preparation and update of CTD modules 2.3 and 3, including associated data and document management
  • Preparation, review and compilation of marketing authorisation dossiers for submission to regulatory authorities around the world (CTD modules 1–5)
• Global marketing authorisations:
  • Marketing authorisation applications (e.g. CP, DCP/MRP, national applications) including the complete procedure management
  • Strategic management in responding to queries from regulatory authorities
• Global life cycle management:
  • All activities following issue of marketing authorisation (e.g. variations, renewals, submission of Periodic Safety Update Reports)
  • Ensuring compliance with all regulatory requirements (e.g. MDR, ICH-Q3D)
• Submission of eCTDs:
  • Compilation, publishing/dispatch, e-submission management and lifecycle activities
• Preparation of GxP-conform translations in all official European languages
• Labelling:
  • Labelling management
  • Maintenance of product information texts taking account of current QRD templates
• Ongoing cultivation of contacts at regulatory authorities around the world (directly and via partners)

We ensure the continuous monitoring of the benefit-risk profile before and after the initial marketing authorisation.

• Responsibility for all safety-relevant aspects during interventional studies (Safety Oversight, SAE management, Ongoing Safety Evaluation, contributing to study documents such as the Clinical Trial Report, Investigator Brochure, Case Report Form, Informed Consent Form)
• Assessment and processing of global adverse reaction reports, always in accordance with the current regulations (MedDRA, E2B[R3])
• Preparation of periodic safety reports (DSUR, PSUR/PBRER, Addendum to Clinical Overview)
• Preparation and update of the safety-relevant sections of the Summary of Product Characteristics and package leaflets (labelling)
• Management of the global company core data sheets
• Monitoring and evaluation of global specialist literature
• Creation of risk management plans and preparation and implementation of educational material and other risk minimisation measures
• Continuous monitoring of the risk profile (signal management)
• Global monitoring of PV obligations in cooperation with our partners around the world
• Comprehensive PV quality system and extensive inspection experience