Our broad experience enables us to help your company with a wide range of regulatory tasks, seeking specialist advice where appropriate, from:

• ‘high profile to urgent timescale’ to….
• routine ‘spreadsheet data collation’ and….
• everything in between.

These are examples of projects recently undertaken:

Identification of likely future regulatory issues for an active ingredient, including hazard labeling and PBT (persistence, bioaccumulative and toxicity characteristics), and including expert views on endocrine disruption, and genotoxicity.

Assessment of existing residue trials data, planning of trials to fill datagaps and project management, including location of suitable contract facilities for the execution of the new trials program.

Review of an entire Annex II database to find datagaps in order for studies to be commissioned, and preparing documentation for the following Annex I renewal submission.

Review of a US registration datapackage, with advice given on the datagaps for a comparable registration in Europe.

Continuous regulatory support, as required, to cross-functional and international regulatory affairs teams where demand outstrips company resource available.

Due diligence – 4 days intensive review in prospective vendor company dataroom and reporting findings to meet strict and short timelines.

Critical competitor analysis from searching publically available information.

Acting as point of key contact during Regulatory Authority review following dossier writing and submission.

Preparation of a full Annex II and Annex III dossier for a new product, to very tight time schedule.