Regulatory Science Solutions

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KINETIC’s dedicated team of experienced regulatory consultants and compliance experts have comprehensive knowledge of North American (US, Canada) and European regulatory frameworks. By leveraging our scientific and clinical expertise, we can help formulate and implement bespoke strategies for your products, providing a clear pathway to facilitate successful interactions with Regulatory Health Authorities (RHA).

We support you through critical milestones of the pre- and post-authorisation regulatory journey including new product launches (eg, biological therapies, radiopharmaceuticals, immunotherapies, small molecule inhibitors, oligonucleotides, cell and gene therapies) line extensions, and product reclassifications. 

Precise preparation for each Regulatory Health Authority (RHA) interaction (eg, US FDA, European EMA, Japan PMDA, China CDE) is essential to prevent unforeseen challenges. Effective planning is crucial in this pathway and a thorough understanding of the RHA intricacies and operational framework is highly advantageous for fruitful interactions and progress of regulatory milestones.

KINETIC can help navigate the challenge of complex regulatory interaction and can assist clients with wide-ranging projects and activities. For example, we are experienced in developing an entire New Drug Application (NDA) or Biologics License Application (BLA) from initiation to submission. Whether you require an urgent US FDA Briefing Book or formulating a regulatory strategy, we can provide expert assistance to advance your regulatory objectives to the next phase. 

Our portfolio expertise includes:

•  Abbreviated New Drug Applications (ANDAs)
•  Investigational New Drug Applications (INDAs)
•  New Drug Applications (NDAs)
•  Biologics License Applications (BLAs)
•  Pre-Market Approval (PMA) Applications
•  Regulatory Strategy GAP Analysis 
•  Submission Project Management 
•  Dossier Preparation and Publishing Publishing (eCTD)

We are uniquely qualified to assist you in preparing and submitting a compelling application to regulators and assisting in the preparation of key scientific Agency meetings. Our extensive experience enables us to understand the exact requirements for a successful interaction with Agencies.

Our teams can support you with the following activities:  

•  Pre-NDA Meetings
•  Type A, B, C, and D Meetings
•  Pre-BLA Meetings
•  FDA Advisory Committee Meetings

We specialize in conceptualizing, developing, and delivering high-quality clinical and scientific subject matter. With over 25 years of international experience in Regulatory and Medical Writing covering all therapeutic areas, we offer expert support for all types of writing projects. 

KINETIC’s Regulatory Writing Team is highly experienced and committed to producing exceptional quality clinical documentation while leading and facilitating an efficient process for our clients. Our team comprises qualified physicians and scientists (MD, PhD, PharmD) all possessing excellent communication skills with longstanding scientific, clinical and regulatory writing experience. 

KINETIC’s proficient writing experts excel in analyzing, interpreting and presenting diverse clinical data. They are adept at efficiently developing high-quality documents that comply with regulatory standards. Combined with their therapeutic area knowledge, our writers ensure the accuracy of data, clarity of content, and consistency of messaging across quality assured for submission-readiness. For example, our writers have extensive experience in authoring, developing and reviewing all Modules of a Common Technical Document submission for a Marketing Authorisation Application (MAA) or a Biologics License Application (BLA). While we may utilise AI-assisted technology in our project work, it cannot be relied on. The Subject Matter Expertise of our regulatory writers is essential to ensure the accuracy of data and content semantics. This ensures our high-quality standards exceed the acceptable regulatory standards. 

Types of regulatory documents we can assist with across multiple therapy areas include:

•  Abbreviated New Drug Application (ANDA)
•  Biologics License Application (BLA) 
•  Briefing Documents for Scientific Advice (EU or US FDA Meetings)
•  Clinical Trial Application (CTA)
•  Investigational Medicinal Product Dossier (IMPD) 
•  Investigational New Drug (IND) Application (US)
•  New Drug Application (NDA)
•  Orphan Drug Designation (EU, UK and US)
•  Pediatric Investigation Plan (PIP) (EU, UK and US)
•  Regulatory Health Authority responses to agency questions
•  Supplemental New Drug Application (sNDA)
•  Medical review and supervision of AI-assisted or AI-generated documentation

Clinical Study / Regulatory Documents

•  Clinical Study Protocol (CSP)
•  Clinical Study Reports (CSRs)
•  Development Safety Update Reports (DSUR)
•  Informed Consent Forms (ICF)
•  Investigator’s Brochure (IB)
•  Lay Language Summaries for Clinical Trial Results
•  Patient Narratives
•  Periodic Safety Update Reports (PSUR)
•  Protocol Amendments
•  Protocol Synopsis

Regulatory Health Authority Submission Documents 

Marketing Authorisation Application (MAA); Clinical and Non-clinical Regulatory Documents/Modules:

•  Module 2.4: Nonclinical Overview 
•  Module 2.5: Clinical Overview 
•  Module 2.6: Nonclinical Summary 
•  Module 2.7: Clinical Summary 
•  Module 2.7.1: Summary of Biopharmaceutical Studies and Associated Analytical Methods
•  Module 2.7.2: Summary of Clinical Pharmacology Studies 
•  Module 2.7.3: Summary of Clinical Efficacy 
•  Module 2.7.4: Summary of Clinical Safety 
•  Module 2.7.5: Literature References 
•  Module 2.7.6: Synopses of Individual Studies 
•  Integrated Summary of Efficacy 
•  Integrated Summary of Safety 
•  Risk Management Plan 
•  Clinical Evaluation Reports 

Product Information 

•  Product Information 
•  Prescribing Information (USPI)
•  Summary of Product Characteristics (SmPC)
•  Patient Information Leaflets (PIL labelling)
•  Core Data Sheet 
•  Responses to Regulatory Authority questions and resolving  challenging queries

KINETIC’s Regulatory Science Team is skilled and adaptive to each client's specific needs and collaborates efficiently with cross-functional groups including preclinical safety, clinical pharmacology, clinical development, pharmacovigilance, biostatistics, medical affairs, regulatory affairs, commercial, and chemistry, manufacturing and control. 

Our strength lies in our regulatory science expertise and customisable processes that meet the specific requirements of our clients. Our collaborative experts aim to work productively to determine the scope of project requirements, identify and mitigate risks, and address and resolve issues to ensure compliant, high-quality technical documents are completed above expectations to support regulatory milestone success.