Our pharmaceutical services mean independence for you
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- Testing of pharmaceutical drugs.
- Development of test methods.
- Material control according to Ph. Eur.
- Development of analytical monographs.
- Solvent residues.
Your partner for Cannabis
- Cannabis Audits
- GMP Consulting
- Official Crosscheck-Expert for the Testing of Drug Samples (§ 65 (4) GDL)
- Expertise with Cannabis since 2016
- Tests on the stability of new and known active substances, finished medicinal products with their related substances and decomposition products. Long-term stability, stress tests (accelerated conditions), in-use stability testing, on-going stability according to ICH guidelines.
Storage according to ICH-guidance
- Storage in the climate cabinet of the Laboratorium Dr. Liebich under various temperature and humidity conditions according to ICH specifications.
Qulified Person § 15 AMG
- For more than 20 years experience as a Qualified Person (QP), formerly production manager and control manager, in various pharmaceutical companies to release your drug for marketing (§16 AMHWV).
- Development of the GMP system, creation of SOPs, forms, PQRs, international GMP company audits.
Counter-sample experts (Gegenprobensachverständige) § 65(4) AMG
- Permission to open officially sealed counterparts.
- Auditing of your contract manufacturers in Germany, Europe, and worldwide in accordance with GMP.
- Realization of all GMP-relevant practical and theoretical work, both in the Laboratorium Dr. Liebich as well as in your local pharmaceutical companies.
- Professional auditor for pharmaceutical manufacturers in Germany and abroad.
Additional services we offer:
Head of Quality Control
- Two quality control directors with many years of experience in freelance (external) work are at your disposal
- Creation and maintenance of your quality dossiers, approvals, change notices, defect processing, edition processing
Texts according to AMG
- Preparation of texts for the primary packaging and carton (outer wrapping), leaflet, technical information, checking of advertising texts.
- Expert report according to § 24 (1) sentence 1 AMG: Preparation of analytical reports on pharmaceutical quality for approval and registration.
- Sybille Herr-Schemitz, a publicly appointed and sworn expert for pharmaceutical analysis by the IHK (Industrie- und Handelskammer).
- Opinion on the delimitation of pharmaceuticals - food.
- Opinion on the delimitation of pharmaceuticals - Dietary supplements.
- Opinion on the delimitation of pharmaceuticals - cosmetics.
Counter-expert (Gegensachverständige) § 105 Abs. 5a Satz 5 AMG (Supervisors)
- Independent counter-expert (Gegensachverständige) appointed by the BfArM for the department "Chemically Synthetic Active Ingredients". The counterparties may be commissioned to produce the required reports on quality within the framework of the fulfillment of the requirements.
Graduated plan officer (Stufenplanbeauftragte)
- The Information Officer collects reports on drug risks that have become known, evaluates them and coordinates the necessary measures.
- Official recognized expertise according to § 63a (2) AMG for Dr. med. Gisela Liebich and Sybille Herr-Schemitz.
- Create and review texts according to AMG. In particular, the Information Officer shall be responsible for ensuring that the label, the package leaflet, the technical information and the advertising match the content of the authorization or registration.
- Authorized expertise according to § 74a (2) AMG for Dr. Gisela Liebich and Sybille Herr-Schemitz.
Do You Have Questions? Would you like to know more? Call us or write us!