Regulatory Affairs Services

Regulatory Affairs Services
Product Description

Midas Pharma offers wide range of pharmaceutical services which includes regulatory affairs services. It offers regulatory support for human medicinal products, veterinary medicinal products and herbal medicinal products in Europe. This includes:

  • drug substance services: development of ASMF/EDMF and US-DMF, CEP applications and life cycle Management) 
  • drug product services: product development/regulatory strategies, pre-submission and/or scientific advice procedures, dossier evaluation and gap analyses, writing chemical-pharmaceutical documentation (CMC), compiling pharmacological-toxicological and clinical documentation, writing quality overall summaries (pharmaceutical-chemical expert reports), etc.

Midas Pharma GmbH

  • DE
  • 2015
    On CPhI since
  • 1
  • 250 - 499
Contract Service
  • Selling Points
    Experienced Technicians; Reputation
  • Supplied from

Midas Pharma GmbH

  • DE
  • 2015
    On CPhI since
  • 1
  • 250 - 499
Contract Service

More Products from Midas Pharma GmbH

  • Reference Products Sourcing

    Product Reference Products Sourcing

    Midas provides worldwide access to reference products (comparator drugs, reference listed drugs (RLDs)) with full service from sourcing to delivery:
    • Competitive sourcing of reference products from international markets
    • Access to “hard to source” reference products (incl. restricted use products as well as biologics)
    • Global network through well-established collaborations with international wholesalers
    • Full confidentiality
    • Full conformity with current GDP rules by using suitable couriers, incl. documented temperature and humidity control
    • Consideration of specific customer requests, e.g. specific batch numbers or particular EU countries
    • Comprehensive documentation package to meet relevant regulatory requirements
  • Intermediates and Chemicals

    Product Intermediates and Chemicals

    Since its foundation, Midas Pharma has been offering services in sourcing and supplying of substances complying with the corresponding industry requirements and uses. Meanwhile our portfolio involves a broad range of intermediates, starting materials and chemicals, covering different industries such as Pharma, Agro, Pulp&Paper. We are experienced  with the increasing regulatory requirements for starting materials and intermediates and have been supporting our customers and manufacturing partners from the initial product qualification throughout its life cycle.
  • Drug Products

    Product Drug Products

    For more than 30 years, Midas is actively providing licenses to market finished pharmaceutical products to its customers in an ever extending international market place. We offer a range of differentiated finished drug products as well as projects for licensing or acquisition from our proprietary and partner developments.
  • Drug Substances

    Product Drug Substances

    With more than 30 years of experience in Pharma, Midas has demonstrated a proven track record & expertise in sourcing and supplying Drug Substances (APIs) required for the pharmaceutical production. We work closely with our manufacturing partners around the globe and are active in more than 700 drug substances. With local representations in 11 countries and in connection with our sourcing offices in Germany, India and China, we are expertly equipped to support your search for suitable API sources worldwide. 
  • Business Development & Licensing Services

    Product Business Development & Licensing Services

    Midas Pharma offers wide range of pharmaceutical services which includes business development & licensing services. With a broad portfolio of services, Midas has access to key decision makers in all business fields of the life science industry.  The customers are active in all areas of pharmaceuticals - Rx and OTC, medical devices - serving the hospital and retail market. Midas has distinct and dedicated teams covering innovative products, platform technologies, consumer healthcare products, as well as generic drugs.  It includes:
    • commercialization strategy
    • promotion
    • search strategy and scouting
    • shortlisting and feasibility checking
    • negotiation
    • transaction support
    • etc.
  • Custom Synthesis Services and API Manufacturing

    Product Custom Synthesis Services and API Manufacturing

    Midas Pharma offers a wide range of pharmaceutical services including development and/or contract manufacturing of early or advanced Intermediates (IMs) and Active Pharmaceutical Ingredients (APIs). Our services are custom tailored and can cover (as required): 
    • process development and optimization
    • up-scaling
    • process validation
    • development and validation of analytical methods
    • synthesis of impurities/reference standards
    • stability studies
    • sourcing of raw materials
    • commercial scale production 
    • etc. 
    All activities are embedded into a GMP environment and supported by regulatory and IP services as per your need and to the extend desired. As a one-stop-shop we can also cover all supply-chain, logistics, import, REACh and other topics to your satisfaction.
  • Finished Product Development Services

    Product Finished Product Development Services

    Midas Pharma offers wide range of pharmaceutical services which includes finished product development services. It provides a complete range of services for developing and manufacturing finished drug products and we have expertise and experience to overcome challenging galenical or analytical hurdles.It includes:
    • modular development support
    • customizing drug product development strategies
    • selecting suitable development partners
    • project management
    • assessing, improving and implementing manufacturing processes and analytical methods
    • onsite supervision of critical development activities
  • Finished Product Manufacturing Services

    Product Finished Product Manufacturing Services

    Midas Pharma offers a wide range of pharmaceutical services which includes finished product manufacturing services. Midas offers a complete package - from API sourcing and technology transfer to variation filing - or just the modular services you require.This includes:
    • identification and qualification of a suitable contract manufacturer
    • technology transfer and customization of equipment
    • dossier and product characteristics
    • etc.
  • Intellectual Property Services

    Product Intellectual Property Services

    Midas Pharma offers wide range of pharmaceutical services which includes intellectual property services. It offers diverse services related to pharmaceutical drug products and the active drug substances (APIs) therein, as well as finished dosage forms (FDFs). It includes:
    • white spot analysis
    • product clearance
    • FTO analysis & development support
    • portfolio & innovation management
    • prosecution & opposition
    • etc.
  • Quality Management Services

    Product Quality Management Services

    Midas Pharma offers wide range of pharmaceutical services which includes quality management services.
    It provides support and services to ensure high product quality and compliance with current valid guidelines and regulations for products used in the pharmaceutical industry - such as APIs, intermediates, excipients, bulk products and finished dosage forms.
    Midas Auditing Services conducts on-site assessments of manufacturing facilities, conducts follow-up activities, offers support, for example gap analysis and mock inspections, and ensures continuous improvement of GMP compliance.

  • Biotechnology Services

    Product Biotechnology Services

    Midas Pharma offers a wide range of pharmaceutical services which include biotechnology services. It offers: 
    • development of biosimilars and proprietary biologicals (starting from gene sequence)
    • cGMP production (microbial and mammalian cells)
    • related bioanalytics (from protein biochemical methods to bio assays)
    • fill & finish and support for medical devices
    The range of biologics covers peptides and proteins (protein hormones, immuno modulators, monoclonal hormones, antibody drug conjugates). Midas is able to provide full range of expertise (protein biochemistry, molecular genetics, cell biology) for recombinant protein development - from gene to commercial production of biopharmaceuticals. The biotech services offer as well biosimilarity testing (full analytical characterization of the reference product and comparability testing) according to the current guidelines of the EMA and FDA.
  • Supply Chain Management

    Product Supply Chain Management

    Under observation of the relevant rules and regulations Supply Chain Management Finished Dosage Forms (SCM FDF) establishes and organizes each and every necessary process for the successful and continuous supply chain of pharmaceutical finished dosage forms:
    • Launch Phase:  re-inventing the pharmaceutical supply chain
    • Commercial Phase: transfer of the project from launch to commercial phase
    • Services: Midas Pharma covers all processes to manage the complete supply chain

Midas Pharma GmbH resources

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