Regulatory Affairs

Our regulatory affairs team helps you navigate this dynamic landscape to ensure that your products and processes meet all relevant regulatory requirements.

Knowledge of the regulations is not enough. Familiarity with the various global regulatory groups and their preferences is essential to achieve the most efficient and successful outcomes. At Health Genic Solutions, we have gained this fluency through frequent interactions with different regulatory sections including FDA, Health Canada, EMA, MHRA, and APAC regullatory bodies, often presenting innovative products to treat challenging indications.

Our team of regulatory experts, comprising top-notch experts with advanced degrees including Ph.D, Pharm.D and M.D has a long-standing reputation for excellence in regulatory strategy and submission preparation.

Health Genic Solutions regulatory solutions include the following:

⦁ Regulatory strategy throughout the lifecycle of your product

⦁ Regulatory application authoring and preparation

⦁ Regulatory program and project management

⦁ Regulatory contact capabilities

⦁ Regulatory submissions

Choosing the right regulatory strategy can mean the difference between a streamlined approval process or a drawn-out, expensive process. We have the proven expertise to design effective regulatory strategies to ensure an efficient approval process. Our team efficiently translates that strategy into the right documents for regulatory agency review, including the following.

Regulatory development milestone meetings and interactions:

⦁ Application Orientation meetings (U.S. AOM)

⦁ Product development meetings

⦁ Pre-submission and pre-application meetings (U.S. FDA, EMA, Health Canada, MHRA, and regulators in APAC)

⦁ EMA-FDA Parallel Scientific Advice

⦁ Oncologic Drugs Advisory Committee meetings (U.S)

⦁ Advisory Committee meetings (U.S)

⦁ Recombinant DNA Advisory Committee (RAC) meetings

⦁ Special protocol assessments (SPAs)

Marketing approval submissions:

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⦁ New Drug Application (U.S NDA)

⦁ New Drug Submission (Health Canada NDS)

⦁ Medical Device Application (U.S., EU, Health Canada)

⦁ Marketing Authorization Application (EU, UK, APAC MAA)

⦁ Premarket Approval (PMA)

Pediatric development:

⦁ Pediatric Written Request for Exclusivity

⦁ Pediatric Study Plan (U.S. PSP)

⦁ Pediatric Investigational Plan (EU PIP)

Designations and expedited programs:

⦁ Fast Track Designation

⦁ Breakthrough Therapy Designation

⦁ Accelerated Approval

⦁ Priority Review Designations

⦁ Orphan Drug Designations

⦁ Priority Medicines (PRIME)

⦁ Innovative Licensing and Access Pathway (ILAP)

⦁ Request For Designation (RFD)

⦁ De Novo Classification Request

Clinical trial application submissions:

⦁ Investigational New Drug Application (IND)

⦁ Clinical Trial Application (CTA)

To discuss your regulatory requirements and how Health Genic Solutions can support you, please email us on contact@healthgenicsolutions.com or call us on +44 7481 096358

Alternatively, you can request a proposal using our online contact form: