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Pharmaceuticals
Clinartis is uniquely positioned to assist with your strategic and global drug development programs. Our team of internal experts, in collaboration with our network of physicians, regulatory professionals, and ex-FDA consultants, will help move your novel scientific discoveries and innovative ideas to the market. Our expertise spans diverse clinical development phases and encompasses a broad range of pharmaceutical products, including small and large molecules, drugs of chemical and biological origin, complex formulations, and alternative delivery methods. Whether you’re planning an IND or NDA submission, or need to choose the optimal regulatory and clinical pathway for 505(b)(2) and ANDA programs, our team will work closely with you to find the most cost-effective solution without compromising quality standards.
We have successfully contributed to developments in the following therapeutic areas:
Infectious Diseases
Neurology
Dermatology
Endocrinology
Cardiovascular
Women’s Health
Musculoskeletal Disorders
Wound Management
Our collaborations with leading key opinion leaders and top clinicians worldwide ensure optimal clinical development program design, rapid recruitment and excellent execution in these specialties.
Medical Devices
Clinartis brings deep cross-functional expertise to medical device and combination product development, from early feasibility through pivotal and post-market studies. Our team of internal experts, together with our network of physicians, regulatory professionals, and ex-FDA consultants, helps device and combination product sponsors navigate the full development lifecycle, including pre-submission strategy, clinical study design, and global regulatory pathways.
We support sponsors across the full range of U.S. and international device pathways, including 510(k) clearance, De Novo classification, and PMA submissions, as well as combination product strategy under 21 CFR Part 4 where a device is paired with a drug or biologic constituent. For sponsors pursuing ex-US approval, our team also helps align development plans with CE marking under the EU MDR and other regional regulatory
Our experience includes a variety of medical device and combination product technologies across multiple therapeutic areas, such as:
Dermatology
Drug Delivery
Wound healing products
Diabetes management
Hemodialysis
Ophthalmic
Cardiovascular interventional devices
Cardiovascular balloons, stents, grafts, and catheters
Light-emitting products (laser) for regenerative therapies
Our comprehensive understanding of these technologies enables us to navigate the complexities of medical device development effectively. At Clinartis, our broad therapeutic experience, strong project management capabilities, and core expertise in quality assurance and regulatory affairs enable us to address specific product development needs and mitigate obstacles often present in pharmaceutical and medical device development.