OP PHARMA is an Italian company providing integrated solutions for the complex regulatory requirements AIFA imposes on new products. We assist with all elements of product market authorization, including but not limited to communication and submissions.
Our main offering is our proprietary data management system, which we developed in-house and which is GMP approved. This is an integrated program that helps our clients manage documentation, and which provides automatic updates, maintains offline access and syncs documents with their partners. This ensures that all changes are immediately apparent to all parties and everyone is up to date on the process.
A roundup of some of the biggest stories from Italian pharma and healthcare, including Italfarmaco’s FDA approval for its DMD treatment; Alfasigma’s acquisition of Galapagos’s Jyseleca, the antibiotics deal between…
The grants and loans allocated by the European Union’s Recovery and Resilience Facility (RRF), a large part of which have been assigned to healthcare, set out to mitigate the economic…
After former CEO Pierluigi Antonelli abruptly announced his departure last month, the Italian mid-cap has signed on former Gilead leader, Jacopo Andreose, as its new chief executive. [I am]…
Angelini Pharma CEO Pierluigi Antonelli has announced that he is leaving his position with immediate effect, posing the question of what comes next for the leading Italian mid-cap. Antonelli,…
The electoral victory of the centre-right coalition in Italy should see far-right firebrand Giorgia Meloni replace former European Central Bank President Mario Draghi as Prime Minister at the end of…
Digitalisation has become a buzz word in in the global life sciences sector. In Italy, digital transformation has taken on special significance as one of the principal goals encompassed in…
The Italian system requires drug companies to go through approvals at a national level with the Italian Medicines Agency (AIFA), only to then confront the country’s 21 regional authorities who…
Historically, SIFI has been a modest local player focused on ophthalmic products, but in recent years the company has set some ambitious goals for itself—becoming a leading force in European…
Seasoned executive Pierluigi Antonelli went from a career in big pharma to Angelini Pharma, a midsized Italian company that has been undergoing major transformation. He shares the motivation behind the…
Collectively representing almost 400 companies operating in Italy, Farmindustria, Egualia (formerly Assogenerici) and Assobiotec respectively promote the interests of innovative pharmaceutical companies—both foreign and Italian-owned— the generics, biosimilars and value-added…
As the European Union’s largest beneficiary of the Next Generation EU (NGEU) package, aimed at boosting the EU’s economy following the COVID-19 pandemic, Italy will receive some EUR 235 billion…
While Italy’s biotech landscape is generally held to be somewhat immature in comparison to more established markets such as Germany, France or the UK, that does not imply a deficit…
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