At Dennis Partners, we know regulatory recruiting. We are committed to creating and maintaining partnerships with our clients while upholding the highest standards of professionalism and ethics. Our team interacts within the marketplace on a daily basis, giving us the ability to locate, screen, and recommend exceptional individuals to your firm. We know how to identify the top performers. Our strength is partnering with you and your business to develop a solution and meet demands for growth while improving efficiency. Let our advanced expertise find the top professionals in the industry to provide a competitive edge to your company.
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Dennis Partner’s focus on only regulatory affairs searches gives them a very good sense of the market, the available talent, and who matches the role. They worked with us diligently to find the right candidate and we ended up making an exceptional hire.
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Alnylam Pharmaceuticals announced that the US FDA approved ONPATTRO™ (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. http://investors.alnylam.com/news-releases/news-release-details/alnylam-announces-first-ever-fda-approval-rnai-therapeutic The FDA approved Amicus Therapeutics’ Galafold, the first oral therapy to treat Fabry disease, a rare, sometimes fatal condition in which accumulation[…]
The FDA approved Kyowa Kirin’s Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of two rare types of non-Hodgkin lymphoma: relapsed or refractory mycosis fungoides and Sézary syndrome. https://markets.businessinsider.com/news/stocks/kyowa-kirin-announces-fda-approval-of-poteligeo-mogamulizumab-kpkc-for-the-treatment-of-mycosis-fungoides-and-s%C3%A9zary-syndrome-1027443628 An FDA Advisory Committee has recommended approval of Paratek’s Omadacycline for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia:[…]
Shionogi & Co announced that, after completing a Priority Review, the FDA has approved Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin receptor agonist for the treatment of thrombocytopenia in adult patients with chronic liver disease. https://www.marketwatch.com/press-release/shionogi-announces-fda-approval-of-mulpleta-lusutrombopag-2018-08-01 Indivior PLC announced that the FDA has approved PERSERIS™, the first once-monthly subcutaneous risperidone-containing, long-acting injectable[…]
Shionogi & Co announced that, after completing a Priority Review, the FDA has approved Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin receptor agonist for the treatment of thrombocytopenia in adult patients with chronic liver disease. https://www.marketwatch.com/press-release/shionogi-announces-fda-approval-of-mulpleta-lusutrombopag-2018-08-01 Indivior PLC announced that the FDA has approved PERSERIS™, the first once-monthly subcutaneous risperidone-containing, long-acting injectable for[…]
AbbVie received FDA approval for elagolix, the first new oral drug approved for endometriosis pain in more than a decade. The drug will be rolled out into the marketplace under the name Orilissa. https://endpts.com/following-some-clean-sweeps-in-phiii-abbvie-gets-an-fda-ok-on-its-top-10-blockbuster-prospect-orilissa/?utm The FDA approved the 12th biosimilar, Pfizer’s Nivestym (filgrastim-aafi), which is a biosimilar to Amgen’s Neupogen (filgrastim), for all eligible indications[…]
Agios Pharmaceuticals said the US FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year. https://www.biospace.com/article/agios-pharmaceuticals-scores-fda-approval-for-tibsovo-second-aml-drug-win-in-less-than-a-year/ SIGA Technologies announced that the FDA approved its filing for oral TPOXX (tecovirimat) as the first therapy with an indication specifically for the treatment of smallpox “to mitigate the[…]
Eagle Pharmaceuticals announced that the U.S. FDA has granted seven years of orphan drug exclusivity in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine hydrochloride. https://www.biospace.com/article/releases/fda-grants-eagle-seven-year-orphan-drug-exclusivity-for-bendeka-bendamustine-hydrochloride-injection-/?s=95 OBI Pharma, Inc. announced that the FDA has granted Orphan Drug Designation for OBI-3424 for the Treatment[…]
Alkermes plc. announced that the FDA has approved Aristada Initio (aripiprazole lauroxil) extended-release product for the treatment of schizophrenia in adults. Aristada was initially approved by the FDA in 2015. https://www.nasdaq.com/article/alkermes-aristada-initio-approved-by-fda-for-schizophrenia-cm987009 The FDA has approved Merz Pharma’s sBLA for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. https://www.thepharmaletter.com/article/fda-approves-neurotoxin-for-excessive-drooling-in-adults Mylan[…]
On Monday the FDA approved the first drug based on compounds found in marijuana. Epidiolex, made by GW Pharmaceuticals, was approved to treat two forms of severe childhood epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm Achaogen, Inc. announced that the FDA has approved ZEMDRI™ (plazomicin) for adults with complicated urinary tract infections (cUTI), including pyelonephritis.[…]
The FDA issued a Complete Response Letter for Valeant’s Duobrii, flagging questions related to the drug’s pharmacokinetics, according to a June 18 statement from the company. https://www.biopharmadive.com/news/valeant-hit-crl-fda-rejection-psoriasis-drug-duobrii/525923/ Shire announced that the FDA has approved a label expansion for CINRYZE® (C1 esterase inhibitor), making it available to help prevent angioedema attacks in children aged 6 years[…]