And more…
Preparation of expert opinions
Health-based limits should be based on safe thresholds, such as Permitted Daily Exposure (PDE) or Threshold of Toxicological Concern (TTC). These thresholds should be the result of a structured scientific evaluation of all available pharmacological and toxicological data, including non-clinical and clinical data.
We offer the professional preparation of PDE (Permitted Daily Exposure) reports in accordance with the EMA guideline ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012).
These expertises are essential for:
- Cleaning validations.
- Cross-contamination risk assessments, especially in ‘shared facilities’ such as those found not only at contract manufacturers (CMO/CDMO).
- Authorisation documentation (CTD Module 3.2.P.5.4).
- GMP compliance during inspections.
Help with borderline products
The correct regulatory classification of a product is crucial for its market access, labelling obligations and safety requirements. Our service supports you in the classification of so-called borderline products, which operate at the interface between different legal areas – e.g. between:
- Pharmaceuticals, food supplements and medical devices.
- Veterinary products, feed additives and biocides.
- Biocides and pesticides.
- Cosmetics and chemicals.
Classification of hazardous substances / dangerous goods
Categorizing materials that pose a risk to health, safety, property, or the environment. Classification helps in the proper handling, storage, and transportation of products.
Testing
for marketability
Evaluating a product or service’s potential
to succeed in the market. This service involves assessing various factors to determine if the product will meet consumer needs, compete effectively, and generate sales.
Expert consultancy, e.g. by telephone
Advising in a form that’s suitable for you.
Pharma Team
Professionals in your industry
Dr. Thorben Bonarius is an experienced regulatory affairs manager with over 20 years of international expertise in the approval and development of pharmaceutical products such as medicinal products and plant protection products.
With a sound scientific background and extensive experience in global R&D structures, he supports pharmaceutical and life science companies in navigating safely through complex regulatory requirements.
Cosichem has a long-standing partnership with Dr. Thorben Bonarius Consult, during which numerous international approval procedures have been successfully completed with his support.