FDA Consulting - INGENES
About INGENES
INGENES regulatory consulting service is a full-service regulatory, product development, and contract manufacturing consulting firm for pharmaceuticals, medical devices, biologics, combination products, and diagnostic devices. INGENES is the go-to consulting partner for companies seeking to bring innovative, safe, and effective products to market within the U.S.
INGENES regulatory consulting was founded on the premise that biotechnology, medical devices, pharmaceuticals, combination products, and diagnostic devices hold the promise of a better future for everyone – making good on that promise requires innovative approaches, world-class science, regulatory know-how, and a team dedicated to bringing all of it together. We believe open communication and transparency are the foundation of a successful outcome for your new product. It’s our obligation to provide an honest assessment, realistic timelines, credible science, accurate submissions, and an effective regulatory strategy to our clients. We take pride in delivering innovative solutions and extraordinary results for clients across the globe – and we know those results are a direct result of the care and commitment we bring to each client engagement.
INGENES regulatory consulting service assists clients all over the globe in addressing nonclinical, clinical, product development, and regulatory compliance challenges. In the past three years, we have served clients across the globe; we have contributed to original Pre-IND, INDs, NDAs, generic drug ANDAs, Drug Master File (DMF), Medical Device Master File (MAF); Medical device Pre-Sub/Q-Subs, 510(k)s, 513(g), De Novo, IDEs, PMA, and BLA submissions.
The cornerstone of this success is found in our team of consultants and staff, comprising subject-matter experts with decades of industry and/or FDA experience. It is this experience that allows us to provide an unparalleled "insider" perspective on how best to navigate your new product from discovery through testing, nonclinical work, clinical trials, regulatory approvals, and ultimately arrive at market in the most efficient manner.
Regardless of the stage of your product's development, INGENES regulatory consulting service has the insight and experience necessary to help you overcome the next set of challenges and bring your product to market in the most responsible and efficient manner possible. With a team of experts and an unmatched track record of achievement in both regulatory approval and product development consulting, rest assured that with INGENES Regulatory Consulting on your side, you are in the best possible position for a successful outcome for your medical devices, pharmaceuticals, biologics, combination products, and diagnostic device approval from the FDA.
