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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The US FDA has approved AcelRx Pharmaceuticals’ DSUVIA, despite abuse concerns. DSUVIA is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. https://www.npr.org/sections/health-shots/2018/11/02/663395669/despite-warnings-fda-approves-potent-new-opioid-painkiller Coherus BioSciences announced that the FDA has approved[…]
The US FDA has approved Novartis/Sandoz’s Hyrimoz, a biosimilar of Abbvie’s Humira, the world’s bestselling prescription medicine. https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoztm-adalimumab-adaz TherapeuticsMD announced that the FDA has approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women. https://www.businesswire.com/news/home/20181029005251/en/TherapeuticsMD-Announces-FDA-Approval-TX-001HR-BIJUVA%E2%84%A2-Estradiol[…]
The US FDA has approved a new treatment for the flu for the first time in nearly 20 years. Roche’s Xofluza (baloxavir marboxil) was approved in people 12 years of age or older. https://www.biospace.com/article/roche-snags-fda-approval-for-first-new-flu-drug-in-20-years/ Principia Biopharma announced that PRN1008, an oral, reversible covalent Bruton’s Tyrosine Kinase (BTK) inhibitor, has been granted Orphan Drug Designation by[…]
The US FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation. https://www.biospace.com/article/fda-approves-pfizer-s-talzenna-for-breast-cancer/ Novartis reported it received a Complete Response Letter from the FDA for canakinumab as a potential treatment for cardiovascular risk reduction. https://www.biospace.com/article/amidst-strong-quarterly-growth-novartis-receives-fda-complete-response-letter-for-canakinumab/ Ocular[…]
The US FDA gave Akcea Therapeutics and its parent company Ionis Pharmaceuticals the green light for Tegsedi (inotersen), a treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Tegsedi was previously green-lit in Canada and the European Union. https://www.biospace.com/article/akcea-therapeutics-and-ionis-pharmaceuticals-snag-fda-approval-for-tegsedi/ The FDA has approved Leadiant Biosciences’ Revcovi (elapegademase-lvlr) for the treatment of adults and children with[…]
This was a big week for Paratek Pharmaceuticals which received US FDA approval for two new molecular entities. On Monday Paratek announced that the FDA has approved SEYSARA™ (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. https://www.nasdaq.com/press-release/fda-approves-seysara-sarecycline-for-the-treatment-of-moderate-to-severe-acne-20181002-00547 Then on Wednesday Paratek[…]
Verastem announced that the U.S. FDA has approved COPIKTRA for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. https://www.marketwatch.com/press-release/verastem-oncology-receives-fda-approval-of-copiktratm-duvelisib-capsules-2018-09-24 Eli Lilly announced that the FDA has approved Emgality (galcanezumab-gnlm 120 mg injection) for the preventive treatment of migraine in adults. https://www.nasdaq.com/article/fda-approves-lillys-emgality-for-preventive-treatment-of-migraine-in-adults-20180927-01236 Pfizer[…]
Teva announced U.S. FDA approval of AJOVYTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. https://www.businesswire.com/news/home/20180914005613/en/Teva-Announces-U.S.-Approval-AJOVYTM-fremanezumab-vfrm-Injection Ironwood Pharmaceuticals announced that the FDA has granted Fast Track Designation for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). http://news.ironwoodpharma.com/news-releases/news-release-details/ironwood-pharmaceuticals-announces-fda-fast-track-designation The FDA has cleared Mersana Therapeutics to resume enrolling[…]
The US FDA approved AstraZenea’s Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukemia. https://www.astrazeneca.com/media-centre/press-releases/2018/us-fda-approves-lumoxiti-moxetumomab-pasudotox-tdfk-for-certain-patients-with-relapsed-or-refractory-hairy-cell-leukaemia.html Amryt announced that the FDA has granted IND clearance for AP101. This enables the Company to begin opening US clinical trial sites as part of its ongoing global EASE Phase III clinical trial in Epidermolysis[…]
Merck announced that the U.S. FDA has approved two new HIV-1 medicines: DELSTRIGO and PIFELTRO: https://pharmaphorum.com/news/fda-approves-mercks-hiv-treatment/ Tetraphase Pharmaceuticals announced that the FDA has granted approval of XERAVA™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). https://ir.tphase.com/news-releases/news-release-details/tetraphase-pharmaceuticals-announces-fda-approval-xeravatm Bayer announced that the FDA approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of[…]