RESOLVE COMPLEX PHARMACEUTICAL QUALITY REGULATORY CHALLENGES

Drug product developers and marketing authorization holders (MAHs) frequently face difficulties preparing their pharmaceutical submission dossiers.

It is especially noticeable in complex situations where particular expertise is needed, such as starting materials definition, potential mutagenic impurities control strategy, apparition of new impurities, complex pharmaceutical forms, innovative drug-device, or novel container closure systems. Moreover, small developers like academic institutions or biotech developing investigational products lack expertise in regulatory Chemistry Manufacturing and Controls (CMC).

An unfavorable outcome of your clinical trial application or marketing authorization applications due to regulatory issues can be detrimental for the product and the whole company.

Ensuring that your submission is optimally managed is a priority for any drug developer to reduce time to market.

We help companies to successfully resolve complex regulatory challenges by providing the adapted expertise to complete your internal team at the right time.

RESOLVE COMPLEX PHARMACEUTICAL QUALITY REGULATORY CHALLENGES

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