Our Generics, Hybrids and Biosimilars (GHBs) business unit has formulated processes and solutions across various therapeutic areas and agents in different jurisdictions.
In addition to our normal range of pharmacovigilance solutions, PrimeVigilance offers tailor-made management of challenging pharmacovigilance agreements (SDEAs), audits schedules & conduct (incl. training management) and ensures regulatory compliance on behalf of our clients and/or their affiliates and vendors, acting as the single point of contact upon request.
We are experts in formulating bespoke processes for GHBs across various therapeutic areas and agents – such as opioids, antibiotics, neurology, oncology, cardiology, NSAIDs, consumer health – through:
- A dedicated team, well-versed in the post-marketing genre and global legal framework for GHBs, who provides consistently high-quality input, supporting management of diverse portfolio(s)
- Building bespoke PV roadmaps to facilitate marketing authorization (MA) or transfer of MAs and lifecycle maintenance – please see also our PVIntegrate™ solution
- An intelligent and mature legacy safety data migration strategy
- Portfolio-tailored processes and templates providing lean, efficient and cost-effective options e.g., bespoke signal management solutions corresponding to product’s characteristics and lifecycle stage or tailored global literature strategy with low recall and high precision to avoid “noise”, but not miss out any relevant references
- Advice on comparative studies (clinical/non-clinical/quality) for biosimilar development; supported by our Clinical Safety Business Unit.
clients have been supported