Pharmaceuticals are defined as substances or preparations of substances intended for use in or on the body and used to cure, alleviate or prevent symptoms and diseases – for both humans and animals.
In the development of pharmaceuticals, we are happy to provide you with consulting and analytical support; for your products or product ideas, we conduct market analyses, consequently evaluate market potential and future opportunities, and provide you with valuable measures for the approval of your pharmaceutical. This also includes the implementation of resulting regulatory aspects, the establishment of a quality management system as well as the application for marketing authorization.
Our consulting services for pharmaceutical development include:
- Strategic management
- Formulation development
- Market analyses
- Product portfolio analyses
- Portfolio brokerage and business development
- Monitoring of clinical trials
- Preparation and review of product specification files and associated documents
- Creation and maintenance of GxP quality management systems
- Clinical and medical evaluation
Our analytical services for pharmaceutical development include:
- Active ingredient analytics
- Formulation development analytics
- Testing of particle size and shape, crystallization
- PET examination (stress tests)
- Bioanalytical support
- Small batch production
- PET examination (stress tests)
- Product related analytics
- Safety testing
Clear, legal requirements are defined for the approval of pharmaceuticals to ensure safe products. This relates to the active ingredient of the product, other raw materials and excipients used, as well as the actual manufacturing, purification and control processes. For this reason, proper analytical solution and validation is an integral part of the pharmaceutical product and is performed under the most stringent requirements of international regulatory agencies (FDA, EPA, ICH, EP, USP and OECD).
Consulting services for drug approval by Tentamus:
- Qualification of the supply chain, including auditing of the respective manufacturers
- Definition of requirements and needs for the EU or national eCTD dossier
- Preparation and submission of the eCTD dossier
- Application for and monitoring of Scientific Advices
- Response to and handling of complaints
- Life Cycle Management, if required after granted marketing authorization
- Monitoring of risk analyses according to ICH Q3D
Analytical services for drug approvals by Tentamus
Not only the composition and the batch formula have to be developed, but also the specifications of the different product stages for release and stability have to be defined. We are happy to develop and validate – as your partner but also if required – new methods according to Ph.Eur., USP or ICH Guideline, tailored to your drug product.
- Pharmaceutical testing for identification, qualification and quantification of unknown impurities
- Investigation of unexplained mass balance losses
- Development of validation protocols
- Perform validation activities, including ensuring compliance with GMP and regulatory requirements
- Development and validation of necessary analytical methods
- Generation of development data for the dossier
- Planning and execution of stability studies for validation batches
During the process as well as after successful marketing authorization, Tentamus offers you support through the diverse tangle of (supra-)national regulatory and legal requirements to adequately market and distribute your products – regardless of whether you are a marketing authorization holder, wholesaler, importer or manufacturer.
Tentamus is happy to assist in the implementation of national and global supply chains – including initial and periodic qualification and tailoring quality management systems to your specific requirements.
Consulting support from Tentamus::
The Tentamus Group offers a full range of consulting services through many, experienced specialists to help you initially and continuously ensure and manage the quality, safety and efficacy of your products:
- Implementierung von GxP-gerechten Qualitätsmanagementsystemen
- Implementation of GxP-compliant quality management systems
- Support for applications to the authorities and inspections
- Support in defect handling
- Qualification of the supply chain, including auditing of the respective companies
- Preparation and maintenance of quality agreements
- Import of active ingredient, bulk or finished drug batches
- Batch certification
- Handling and storage of reserve and reference samples
- Support for validation and qualification activities
- QM activities, including but not limited to change control, deviations, risk management, and training
- Life cycle management of respective product approvals – including preparation and submission of change notices
Assumption of responsibilities as a functionary, e.g. Qualified Person, Responsible Person for Wholesale or Narcotics
Through our GMP-certified laboratories with their own manufacturing or import authorization, we not only offer routine batch certification and market release, but also provide support in the context of lifecycle management, e.g. in the issuance of QP Declarations, if integrated into your supply chain.
Continuous quality control and pharmaceutical testing by Tentamus
The quality control of your products is carried out in the laboratories of the Tentamus Group according to standardized, verified and validated procedures – either at the respective pharmacopoeia level or on the basis of our own developments. In doing so, we cover raw materials, semi-finished goods, finished drugs, cytostatics, narcotics and medical devices as well as medicinal cannabis.
In this context, we offer the following pharmaceutical testing services:
- Microbiology, sterile
- Microbiology, non-sterile
- Residue analysis
- Continuous stability testing, e.g. according to ICH standards
In addition to the testing of stability samples, the laboratories of the Tentamus Group offer to establish the stability programs internally according to your specifications based on qualified climatic conditions, so that transport and removal expenses can be reduced for you here.
Microbiological testing of pharmaceuticals
Microbiological testing, including non-sterile pharmaceutical preparations and substances, allows us to detect microorganisms in raw materials, the production environment and formulated products. Our laboratories can offer you the complete range of laboratory analyses for this purpose.
Whether you are validating procedures, monitoring processes, evaluating the efficacy of cleaning or disinfection procedures, or looking for contaminants and undesirable organisms in the product, we can help.
- Microbiological testing according to pharmacopoeia
- Disinfectant testing
- Identification of organisms
- Microbial limit test
- Microbial contamination (bioburden analysis)
- Environmental monitoring
- Effectiveness of antimicrobial preservation (antimicrobial effectiveness)
Physio-chemical testing of pharmaceuticals
Our laboratories examine your pharmaceuticals using state-of-the-art technology in accordance with national and international pharmacopoeias. Starting materials, active ingredients, sterile and non-sterile drug products as well as specially regulated products (e.g. narcotics, cytostatics) can be tested using chemical analyses.
Pharmaceutical testing for impurities and residues
Impurities can already enter the raw material to be used for a drug product or contaminate the product during the production process. These can be crop protection products on the one hand, but also chemical substances such as solvents, ethylene oxide, dioxane or sulfated ash on the other.
Recent international examples show the scope of this and consequently Tentamus is happy to support you in the investigation to detect any residues and to be able to initiate appropriate measures. We base our analyses on the applicable regulations and legal limits.
Already in the context of the application for marketing authorization, the various legal requirements must be met – but they must also be checked in the context of stability studies and batch certification. We are happy to advise you on the right choice of packaging material and qualification of suppliers, and check your labeling and product information for conformity with legal requirements and registration documents.
The following laboratories from the Tentamus Group offer pharmaceutical testing and/or consulting: