Our Partnerships

Here we would like to show you our partnerships:

Biokanol Pharma GmbH

Biokanol Pharma GmbH stands for individual services around your product.
From visual control, packaging/reworking alone to labelling, serialisation, bundle packs sealed in full wrap in any batch size whatsoever all activities are efficiently performed in compliance with GMP.

You are welcome to contact us for procuring the required printed materials. Shipment as well as – upon request - release for placing on the market are a matter of course to us.
Storage and production are performed in temperature-controlled rooms. Two cold-storage facilities permit the processing of refrigerated goods.

A good network and many years of experience almost always find a pragmatic solution to your requirements. Biokanol Pharma was founded in 1998 and has 40 employees today.

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Homepage: www.biokanol.de

Dr. Regenold GmbH

Dr. Regenold GmbH is specialised in development, regulatory and market access. Founded in 1994, we have helped many clients progress their product developments, by providing scientific and regulatory advice, through to gaining regulatory approval and marketing authorisation for their medicines and medical devices both nationally and internationally.

In 2001 Dr. Regenold founded regulanet® which is a network of independent regulatory consultancies with representation in over 90 countries throughout the world.

Med-X-Press

Our cooperation partner Med-X-Press is a recognised service provider for the pharmaceutical industry, completely covering the following business areas:

- shipment of samples & mailing
- warehousing & distribution
- picking & finishing, packaging and re-packaging  pursuant to section 13.1 AMG (German Medicinal Products Act)
- handling of narcotics (including order-to-cash management)

Our core services are supplemented by customised e-shops and considered “best practice” by our customers. Three cold-storage warehouses and one narcotics warehouse for approx. 1,000 pallet slots complement our range of logistics services. As a matter of course we provide all our services in top GMP quality, meeting the requirements set by sections 47, 52a and 13.1 of the German Medicinal Products Act (AMG). Founded in 2005, the medium-sized family enterprise has been  growing continuously and meanwhile employs around 300 members of staff.

MPC - Müller Pharma Consult

Dr. Sylvana P. Müller (Owner of MPC) is a preclinical development consultant with more than 20 years of experience in preparation of in-vivo pre-clinical studies, expert statements, monitoring and audits (GPL and GCP) and managing and/or coordination of pre-clinical studies (Pharmacology, safety pharmacology, pharmacokinetics and toxicology) and small clinical trials. Prior to becoming an independent consultant, she was managing director of FORIM GmbH (from 2006 until May, 2014), a consultant company with clients from the pharmaceutical and medical device industry.

Protagen Protein Services GmbH

Protagen Protein Services GmbH is an international leading specialist in the fields of Protein Characterization, Biopharmaceuticals and GMP-compliant protein analysis. 16year’s experience in business and the comprehensive, GMP compliant spectrum of analytical methods ensure highest quality the customers in the pharmaceutical, biotech, and the entire life science industry.

Besides a large number of new biological entities (NBE) currently in development, PPS has supported a vast number of customer projects to develop biosimilars such like Etanercept, Rituximab, Infliximab, Trastuzumab, Erythropoietin, Adalimumab, Bevacizumab, Filgrastim, Insulin, Interferons and several other products. PPS data are accepted by EMA, FDA, and Korean-FDA for scientific advices, phases 1 to 3 or release testing.

Sumika Chemical Analysis Service, Ltd. (SCAS)

SCAS Group Laboratories, as the first of its kind in Asia-Pacific region, shall provide versatile analysis services to meet requirements from petroleum, chemical, semi-conductor and electronics, and pharmaceutical industries through analytical expertise developed by SCAS (Japan) 40 years of its history.
As the first overseas base, SCAS set up Singapore Laboratory "SCASS" in 1997 and, in 2007, established an organically linked laboratory "SAES" in Shanghai, China. "SCAS Europe" was also found in Belgium in 2007 to expand its analytical business sphere. In2011,"SBB" was established as a joint venture for the bioanalysis services located in Korea. "SCAS Korea" was established in order to provide broad service for various industries supporting green society, "SACS Korea" and "SCAS Taiwan" were founded in 2012 and 2013, respectively.

Toxicological Consulting Services

Toxicological Consulting Services was founded in 2012 by Dr. med. vet. Ingo Stammberger who is a board certified expert in pharmacology and toxicology. He was almost 25 years with "big pharma" and has hands on experience in genetic and in general toxicology. Toxicological Consulting Services provides toxicological support for the investigation and development of small molecules, biotherapeutics, and biosimilars from the early discovery phase, the preclinical and the clinical development stages up to life-cycle-management for marketed products. Special expertise is available in assessing (genotoxic) impurities (starting materials, intermediates of synthesis, degradation products), extractables and leachables and cross-contaminants (PDE-calculation for cleaning validation process).

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tpi consult GmbH

tpi consult GmbH advises thru Prof. Dr. Stefan Hockertz growth companies focused on technology in the pharmaceutical, chemical, food and cosmetics industry as well as all companies that deal with pharmacological and toxicological matters. In doing so, tpi consult offers customised consultation concepts with a highly scientific approach, which demonstrate successful, reliable, individual solutions. tpi consult’s support covers toxicological-pharmacological expert reports as well as long-term consultancy on Management on Demand.

 

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