Pharmaceutical Testing

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

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

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
• Chem­i­cal/­physio-chem­ical
• Biolog­ical
• 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.

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: