ls-bg

Orphan Drug Applications

Combination Drug/Device Products

ls-bg

IND Exemptions as eCTD

Type A,B and C Meetings

ls-bg

Drug Master Files

ls-bg

Drug Master Files

Mock Advisory Committee (s)

Medical and Regulatory Affairs Consulants.

Where Success Matters.
Experienced. Trusted. Dedicated.

Regulatory AffairsEstablished in 1990 Clementi Associates Ltd. has provided high level consulting services to the drug and device industry during the evolving regulatory landscape.  We are at a time of true global drug development and registration.  Concurrently, manufacture sites are able to provide drug products to global communities.  Many more people are treated and exposed to drugs now more than ever before.  This combined with data mining technics are altering our understanding of drug safety and drug development.

The consequence of these developments are two fold: 1) regulator inspection must be more demanding and documentation must be complete and extensive at the time of inspection, 2) post-marketing activities must be comprehensive and complete so that adverse event detection occurs soon after product introduction.

With the advent and acceptance of ICH guidelines and eCTD development paths appear clear and straightforward at the outset.  Moving a product from Phase I to Phase III and a first pass approval appears almost “cookbook” compared to 20 years ago.   But we all know this rarely happens to any company.  The mechanism of action remains elusive and based on developments in biology.  Unexpected side effects occur and their frequency and reversibility must be addressed prior to registration.  Thus, new assessments and views are required for success.