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 analyses to determine GMP / ISO 13485 compliance
  • Tailor-made optimization of existing QM systems
  • Creation of SOPs and documents
  • Inspection preparation for inspections (GMP, GDP, ISO 13485)
  • Supplier audits (pharmaceutical manufacturers, manufacturers of active ingredients, packaging materials and distribution, certified GMP auditor)
  • Internal audits
  • Employee training for GxP, ISO 13485

Interim Solutions

  • Qualified person according to §7 AMBO
  • Business manager for the manufacture and wholesale of pharmaceutical products (Possibility to take over these functions as an interim or long-term solution)

Regulatory

  • 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
  • Search of 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
  • Participation in the design team
  • Support with risk analyses

Food supplements

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

Cosmetics

  • 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 managemet

  • Creation of project plans
  • Advice 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 the trainee year as dispensing pharmacist at Sonnenapotheke Linz and then she worked in a leading position at the start-up company ThioMatrix 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 deals with the production of 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. In 2020 she founded Langoth Pharma Consulting.
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 the respective interface-problems
  • Representation of companies in front of 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 (small molecule) that was centrally approved by the EMA
  • QP and project management activities for a biotechnological product from South Korea
  • Establishment of a pharmaceutical quality management system in companies that act as sponsors for clinical studies
  • Quality audits by GMP manufacturers, contract research organizations and bioanalytical institutions
  • Regulatory and GxP advice for a manufacturer of a herbal product
  • Business manager for the manufacture and wholesale of pharmaceutical products and responsible person for controlled substances

Network

MC Toxicology Consulting
toxicology.at

RD&C Research, Development & Consulting GmbH
rdc-concepts.com

Nora Gedeon, Consultant Clinical Research
noragedeon.com

Charlotte Reither, Consultant
move-on-up.consulting

Rainer Fehringer, Photographer, Filmmaker
rainerstudio.com