Langoth Pharma Consulting

Langoth Pharma Consulting offers consulting and services for pharmaceutical companies as well as medical device, food and cosmetic companies. Langoth Pharma Consulting sees itself as a trusted partner with the aim of finding pragmatic and efficient solutions.

Consulting and Services

QP Services

  • Interim qualified person
  • Batch release (clinical and commercial batches)
  • QP declarations
  • Deviation management
  • Batch record review
  • CAPA management
  • QP training und coaching

Quality Management System (QMS)

  • GAP analysis to determine GMP / ISO 13485 compliance
  • Customized optimization of existing QM systems
  • Creation of SOPs and documents
  • Preparation for inspections (GMP, GDP, ISO 13485)
  • Supplier audits audits of manufacturers of pharmaceutical, active ingredients and packaging materials, and distributors (certified GMP auditor)
  • Internal audits
  • Employee training in GxP, ISO 13485

Interim Solutions

  • Qualified person according to §7 AMBO
  • Managing Director under trade law for the manufacture and distribution of pharmaceutical products
    (With option to take over these functions as an interim or long-term solution)


  • Development strategies for medicinal products (focus on CMC), medical devices, cosmetics, dietary supplements
  • Creation and review of the CMC documents (Chemistry, Manufacturing & Controls)
  • Regulatory status of borderline products (pharmaceuticals / medical devices / cosmetics / food supplements)

Product development

Medicinal Products

  • Development of product ideas
  • Finding contract manufacturers and contract laboratories
  • Advice on the production of clinical batches
  • Creation of CMC documents for IMPD / CTD
  • Planning of stability studies
  • Advice on defining specifications

Medical devices

  • Development strategy
  • Creation of a design dossier
  • Accompanying the design control process
  • Training employees on design control processes
  • Member of the design team
  • Support with risk analyses

Food supplements

  • Development of a product strategy
  • Finding suitable contract manufacturers
  • Support with labelling
  • Control and approval of the advertising material


  • Support in product development
  • Search for contract manufacturers
  • Support with labelling
  • Control and approval of the advertising material
  • Creation of the Product Information File (PIF)
  • CPNP notification

Project management

  • Project planning
  • Advice on and coordination of product development projects
  • Takeover of projects or sub-projects
  • Design control activities

About Me

Mag. pharm. Dr. rer.nat. Nina Langoth-Fehringer / Managing Director Nina Langoth-Fehringer studied pharmacy at the University of Vienna and did her PhD in the field of pharmaceutical technology. She completed her internship as a dispensing pharmacist at Sonnenapotheke Linz and then she worked in a leading position at the ThioMatrixthe start-up company in Innsbruck. After another year as a pharmacist, she began her 15-year career in the pharmaceutical industry. She worked for Croma Pharma GmbH for more than 12 years, where she held various management positions (Head of Research & Development, Qualified Person). Most recently, she worked at Cannabeo GmbH, a start-up company that produces medical cannabis and cannabidiol (CBD).
Dr. Langoth-Fehringer has many years of experience in product development (medical devices, pharmaceuticals, cosmetics) and as a qualified person. She founded Langoth Pharma Consulting in 2020.
Download CV

expertise & projects

  • Overview of the entire process chain for product development projects (R&D to launch)
  • Support during the entire development process from R&D to development, production, approval, marketing and sales
  • Experience with the different stakeholders/departments involved in product development and their respective interface-problems
  • Representation of companies with customers and authorities
  • Supervision of contract manfucturing projects
  • Finding strategies for product development projects
  • Design reviews / milesstone reviews / gate reviews for projects from R&D status to product launch
  • Organization of manufacturing of study medication
  • Project management for an ophthalmic drug product (small molecule) that was centrally approved by the EMA
  • QP and project management activities for an Asian biotechnological
  • Establishment of a pharmaceutical quality management system in companies sponsoring clinical studies
  • Audits of GMP manufacturers, contract research organizations and bioanalytical institutions
  • Regulatory and GxP advice for a manufacturers of a herbal products
  • Business manager for the manufacture and wholesale of pharmaceutical products and responsible person for controlled substances

Collaboration Network

RD&C Research, Development & Consulting GmbH

Nora Gedeon, Consultant Clinical Research

Christina Nicolodi, Regulatory Affairs Consultant Services

Charlotte Reither, Consultant

Rainer Fehringer, Photographer, Filmmaker