NextPharma CTS
NextPharma Clinical Trials Services
NextPharma provides a full range of pharmaceutical services,
including pharmaceutical development, clinical trials services,
analytical services and commercial manufacturing and packaging.
NextPharma can provide expertise in a broad range of pharmaceutical
dosage forms such as solids, liquids and semi-solids in standard or
innovative packaging. From six sites located in Europe, we now serve
over 150 customers across six continents.
NextPharma is a leading provider of clinical trials services (CTS) including
- formulation development
- manufacturing of investigational medicinal products (IMPs)
- packaging design
- comparator procurement
- blinding
- primary and secondary packaging
- analytics
- stability testing
- microbiology testing
- methods development
- methods validation
NextPharmas highly experienced team handles a variety of
pharmaceutical forms for Phase I-IV clinical trials in accordance with
Annex 13 EU-GMP guidelines in Europe and U.S. FDA guidelines supported
in Europe by our dedicated Qualified Persons.
Services
NextPharma provides assistance in the implementation of tailor-made
packaging design for your specific study including safety, compliance
and premarketing as well as requirements planning, purchasing of
packaging materials and sourcing of comparative medication.
We offer bulk manufacturing of active and placebo dosage products,
with expertise in blinding of dosage forms and deblistering of
commercial products. Additional services include filling, packaging,
randomization, labelling design and printing. We can also handle
processing of narcotics.
We provide expert analytical services, stability management and also
our routine testing services include method development, transfer
analytical and stability testing during studies, compared release of
blinded forms. Drawing up of randomization lists and emergency letters
is available. Our specialty are blinding by over-encapsulation and the
manufacturing of blister cards by hot sealing.
Special Product Capabilities
NextPharma can handle your special product needs including cytotoxic
(lyophilized and solutions), biologics (lyophilized and solutions),
hormones (solid and semi-solid), cephalosporins (solid) and narcotics
in addition to conventional drug classes (solid, semi-solid and
liquids).
Logistics: Storage, Distribution, Reconciliation and Destruction
We offer short-term and long-term storage under GMP conditions at
controlled room temperature, refrigerated and frozen, including
cryogenic storage. We have long-term 3rd party relationships with
couriers and depots worldwide. Distribution of drugs and patient kits at
controlled room temperature and refrigerated temperature conditions is
also part of our core business. Services for return and reconciliation
of drugs as well as management of drug destruction are also offered.
We already have very good experience and currently distribute drug
product and patient kits to clinical sites around the world. We provide
flexibility in shipping options to our clients to meet their needs. This
includes use of commercially available validated shippers for
temperature-controlled shipments.
With more than 30 years of expertise in the CTS business to ensure a
seamless transfer process for customers CTS projects. Our experienced
project management team works to ensure that our services go beyond your
expectations and needs.
Contact NextPharma to see how we can meet your clinical trials services and needs at www.nextpharma.com/CTS or by ask our CTS team how we can help, call us on +49 (0) 160 445 0566 or email cts-info@nextpharma.com.
+49 (0) 160 445 0566
