– Analytical method development and validation

– Process optimization and continuous process monitoring

– Registration and commercial stability study

– Microbiological and chemical testing of Raw Materials, IPC and finished product

– Cleaning method development and validation

– cGMP-compliant laboratories

– Premium quality track record

– Quality by Design approach : design of experiments to establish design space

Skyepharma’s oral drug delivery services include regulatory support and project management to increase the likelyhood of your product approval.

We have a long track record of supporting regulatory approvals for oral modified release products in international markets, including the US, Europe and many other countries. We regularly support our customers in compiling their dossiers and we provide advice on submission and product maintenance processes.

We ensure :

– Registration support and post-approval strategies
– Regulatory agency inquiries and inspections
– Lifecycle management support

Certifications :

US-FDA (PAI) : 1998, 2001, 2002, 2003
US-FDA cGMP : 2007, 2010, 2013, 2015
Korean-FDA PAI : 2012
ANSM : 2012, 2014, 2017
ANVISA : 2013

– The facility is an EMA/FDA approved development & manufacturing facility with experience in US and EU regulatory filings in collaboration with Big Pharma.
– Last FDA inspection was carried out in 2015 with zero 483 issued.

We currently apply Quality by Design approach for our customers’ projects, as part of our value proposal’s support services program.

Quality by Design is a development tool which focuses on effective drug development. : it is a systematic and dynamic approach that assumes that quality is built in by design and is continuously improved. Quality by Design aims to better explore the characteristics of molecules, in order to better master the manufacturing process having identified the critical parameters.

With a view to customer satisfaction, framed by pharmaceutical industry strict standards towards quality management, Skyepharma manages this innovative development approach that allows process understanding and control, based on quality risk management.

By doing so, we secure the safe and effective drug supply to patients, whilst significantly improving our manufacturing quality performance.

Additional advantages include the reduction of finished product controls, shortening the time of batch release and reducing the number of out-of-specification. From a regulatory perspective, the reduction of variation submissions in post-marketing phases is an important point in terms of resource management and cost.