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)
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
- 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
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 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.
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 GmbHrdc-concepts.com
Nora Gedeon, Consultant Clinical Research
noragedeon.com
Christina Nicolodi, Regulatory Affairs Consultant Services
nicolodi-consulting.com
Charlotte Reither, Consultant
move-on-up.consulting
Rainer Fehringer, Photographer, Filmmaker
rainerstudio.com