Global Regulatory Services at Medicon Valley Alliance in Copenhagen

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21/3/2018

Global Regulatory Services was present at the “New Updates in Drug Formulation & Bioavailability” conference on 21 March 2018 at the Medicon Valley Alliance in Copenhagen, Denmark.

The conference provided a forum to hear and learn from a number of presentations and talks on new developments and innovations in drug formulation and bioavailability. The presentations included:

the use of starch Pickering emulsions rather than surfactants or traditional emulsifiers for drug formulations;
accelerating the development of dry powders for inhalation;
a novel spray drying technique for use with vaccines and haemophilia products as well as inhalation products;
the challenges of developing improved and patient friendly formulations for the delivery of biologics to patients;
novel formulation methods for oral medicines for children including orodispersibles and Minitabs;
a novel methodology for the assessment of drug exposure in the CNS (intra brain drug exposure) during drug development;
a new and innovative method for formulating poorly soluble drugs using an amorphous system based on Upsalite and a mesoporous system.

It was a fascinating and stimulating conference which highlighted the continuous efforts being made by the innovative Life Science industry to tackle the formulation and drug delivery challenges which are needed to improve the delivery of medicines to a wide demography of patients of all ages.

If you are developing innovative drug formulations and need support or advice regarding your Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP), Global Regulatory Services has specialists around the world who are on hand to help. Many GRS professionals are accredited auditors and even include ex-regulatory agency staff so they will know what the regulators are expecting. In turn this will help you to be compliant first time around and maximise the opportunity to reach your target market before your competitors.

Global Regulatory Services are specialists in all aspects of Chemistry, Manufacturing and Control (CMC), an important part of any submission to the regulators. Our professionals are also experienced with regulations applicable to the use of medicines for the treatment of children (paediatrics) and compliance with the EU Paediatric Regulation which entered into force on 26^th January 2007.

Please contact GRS with your specific regulatory compliance requirements.