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Pharmaceutical Testing

Full service instead of just pharmaceutical testing

Our laboratories are versatile and highly specialized in their subject areas. With Tentamus, you have our qualified team with many years of experience in the field of pharmaceuticals at your side.

Do you require help or further information?

Contact us! We are happy to advise you:

zexalabs.com
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In addition to classical pharmaceutical testing, we support your company in the development, approval or quality control of your pharmaceutical products. We are also happy to pass on our specialized pharmaceutical-analytical knowledge in training courses on a wide range of topics, or to advise you on the classification or differentiation of pharmaceuticals from related product classes, such as nutraceuticals, medical devices, etc.

  • Pharmaceutical development
  • Approval of pharmaceuticals
  • Manufacturing and marketing of pharmaceuticals
  • Packaging and labeling of pharmaceuticals
  • Laboratories for pharmaceutical testing

How does Tentamus support you during

pharmaceutical development?

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
  • Market analyses
  • Portfolio brokerage and business development
  • Preparation and review of product specification files and associated documents
  • Clinical and medical evaluation
  • Formulation development
  • Product portfolio analyses
  • Monitoring of clinical trials
  • Creation and maintenance of GxP quality management systems

Our analytical services for pharmaceutical development include:

  • Active ingredient analytics
  • Formulation development analytics
  • Testing of particle size and shape, crystallization
  • PET examination (stress tests)
  • Safety testing
  • Bioanalytical support
  • Small batch production
  • PET examination (stress tests)
  • Pharmacology
  • Product related analytics

How does Tentamus support you in the

Approval of pharmaceuticals?

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
  • Preparation and submission of the eCTD dossier
  • Response to and handling of complaints
  • Monitoring of risk analyses according to ICH Q3D
  • Definition of requirements and needs for the EU or national eCTD dossier
  • Application for and monitoring of Scientific Advices
  • Life Cycle Management, if required after granted marketing authorization

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
  • Development of validation protocols
  • Development and validation of necessary analytical methods
  • Planning and execution of stability studies for validation batches
  • Investigation of unexplained mass balance losses
  • Perform validation activities, including ensuring compliance with GMP and regulatory requirements
  • Generation of development data for the dossier

How does Tentamus support you in the

Manufacturing and marketing of pharmaceuticals?

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
  • Support for applications to the authorities and inspections
  • Qualification of the supply chain, including auditing of the respective companies
  • Import of active ingredient, bulk or finished drug batches
  • Handling and storage of reserve and reference samples
  • QM activities, including but not limited to change control, deviations, risk management, and training
  • Preparation and maintenance of quality agreements
  • Batch certification
  • Support for validation and qualification activities
  • 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
    Batch certification by Qualified P

Batch certification by Qualified Persons according to Directive 2001/83/EC

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
  • Chemical/physio-chemical
  • Residue analysis
  • Microbiology, non-sterile
  • Biological
  • 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.

We offer the following microbiological tests:

  • Microbiological testing according to pharmacopoeia
  • Identification of organisms
  • Microbial contamination (bioburden analysis)
  • Effectiveness of antimicrobial preservation (antimicrobial effectiveness)
More information on Microbiological Testing
  • Disinfectant testing
  • Microbial limit test
  • Environmental monitoring

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.

More information on Residue Analysis

Packaging and labeling of pharmaceuticals

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.
As part of both product development and stability testing, the Tentamus laboratories will be happy to check the extent to which packaging materials have an influence on your products and any impurities.

Overview of laboratories for pharmaceutical testing of the Tentamus Group

The following laboratories from the Tentamus Group offer pharmaceutical testing and/or consulting: