Expert consulting.
Quality Management
Toxicology
Crisis Management
EU approvals
Quality Management and Quality Assurance
BIOSERV’s experienced quality experts support you in implementing or maintaining quality management concepts in accordance with the current requirements of national and international standards. As part of your quality assurance, we carry out company inspections and quality assurance measures for you. Whether you need regular support, preparation for upcoming external audits, conducting internal audits, support during audits or document preparation, we offer comprehensive solutions.
Our consultants are “higher level
Labelling Inspection
Compliance with national and international standards for product labelling is a complex area, with new regulations and directives coming into force all the time. Depending on the product category, there are numerous regulations for legal labelling. BIOSERV supports companies in the legally correct implementation, e.g. on the basis of the European Food Information Regulation (FIR, EU Regulation No. 1169/2011) or according to the EU Cosmetics Regulation (EC) No. 1223/2009. BIOSERV’s team of experts also provides support in the use of health claims and advertising statements.
BIOSERV offers labelling tests for the following regulations
HACCP approaches to food hygiene
Regulation (EC) No 852/2004 requires food business operators to establish, implement and maintain a HACCP system at all stages of production, processing and distribution. BIOSERV develops individual, pragmatic and lean HACCP concepts for all companies in the food industry and food trade that meet the applicable legal requirements. BIOSERV also checks that existing documents are correct and up to date and provides support in the event of official complaints, new developments and restructuring.
Who has to implement HACCP concepts?
Toxicological analyses, Expert opinions and assessments
The scientific analysis of health risks that may arise from exposure to harmful substances is an essential part of product development, approval or crisis management for a wide range of product groups. The risk may be caused by chemicals, leachables from products, residues or (microbial) contaminants.
BIOSERV’s experienced toxicologists and interdisciplinary team of scientists analyse individual problems and assess existing risks in the context of relevant standards and legal frameworks.
Safety evaluation for cosmetic products and notification
According to the EU Cosmetics Regulation (EC) No. 1223/2009, cosmetics manufacturers must subject each product to a comprehensive health and safety assessment before it is placed on the market. This is to ensure that the products meet the legal requirements and do not pose a risk to consumers.
Our experts evaluate all ingredients, taking into account the foreseeable use, manufacturing processes and product characteristics. All the information and conclusions are recorded in a safety report at the end of the assessment. This is the most important part of the so-called product information file, which is used by manufacturers to document that the cosmetic product is safe for human health under “normal and reasonably foreseeable conditions of use” and that it meets all other legal requirements. We can also take care of the necessary notification of your products on the EU portal CPNP in accordance with Articles 16 and 19 of the EU Cosmetics Regulation.
Training Courses
For companies in the food, pharmaceutical, medical device and healthcare industries, continuing education and training for professionals and career changers is critical. This is because standards and legislation are constantly changing and manufacturers, processors and operators need to keep up to date.
Specifics in the food sector
Our training programmes
BIOSERV offers a wide range of training courses for employees in the food industry, particularly in the area of quality assurance. In addition to in-house consultancy, BIOSERV also offers online training courses. The modular training courses are always tailored to individual needs.
Hygiene training and follow-up instruction in accordance with § 43 of german Infektionsschutzgesetz
Hygiene training and follow up instruction in accordance with Section 43 is mandatory for employees in food businesses and the employer is responsible for providing it. All employees who come into contact with food must be trained annually in food hygiene and every two years in infection control.
Duration
approx. 60 minutes
Training dates
28 January 2025, 6 May 2025
Minimum number of participants
6 people*
Fee
59.00 plus VAT
Basic knowledge of prepacked product labelling
The seminar is aimed at food business operators or employees who are responsible for the labelling of pre-packed products for the end consumer.
Duration
approx. 3 hours
Training dates
29 October 2024
Minimum number of participants
On request
Fee
On request
Introduction to the assessment of biological safety of medical devices (DIN EN ISO 10993)
Biological safety is critical to the successful approval of a medical device. According to Annex I of the MDD, products must fulfil essential safety and performance requirements. This means that they must be biocompatible and not cause toxic effects, inflammation or other adverse reactions.
Duration
approx. 6 hours
Available dates
On request
Minimum number of participants
On request
Kosten
Auf Anfrage
