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SERVICES

RCSS supports regulatory and scientific activities across the full product lifecycle—from early clinical development through post-approval. With deep expertise in global regulatory requirements, including those of the U.S., EU, Canadian, and Israeli markets, RCSS offers strategic, personalized guidance to help life sciences companies advance their products efficiently and compliantly.

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​​​​Whether you’re preparing for an IND/CTA, optimizing clinical program, responding to health authority feedback, seeking marketing authorization, or managing post-approval obligations, RCSS provides comprehensive, stage-specific regulatory and scientific support customized to your product’s needs.

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Where is your product today? Choose a stage below to learn how I can help.​​

Drug Development
Marketing Authorization
Post-approval regulatory activities

International Collaboration & Capability

I collaborate with trusted regulatory and clinical partners in the United States, the European Union, and Canada.

This international network enables the effective management of large, complex development programs, as well as the precise execution of technical activities such as regulatory publishing.

PRODUCT DEVELOPEMENT SERVICES

​RCSS supports the initiation of clinical trials at all stages—from first-in-human studies, through dose-escalation trials, to late-phase efficacy trials—providing both regulatory affairs and scientific support to ensure strategic and compliant development.​​​

Regulatory Process & Strategy
  • Regulatory pathway
  • ​Development strategy
  • Expedite program 
  • Compassionate use
CMC Regulatory/Scientific Support
  • Gap assessment per trial stage
  • Study design (e.g. viral study, stability, process development, validation)​
  • Protocol/report authoring 
  • Deviation investigation
  • Responses to Agencies
Regulatory Submission
  • Authoring all CMC sections (i.e. module 3 and QoS) for INDs and CTAs/IMPDs
  • Review full submission
  • Content compliance
  • Responses to Agencies
  • Submission maintenance 

Drug
Development Services

Health Authority Meetings
  • Key questions identification
  • Briefing package preparation/review 
  • Meeting management
  • Minutes preparation
Clinical Development
  • Trial Design (e.g. Methodology/endpoint Inclusion/exclusion criteria)
  • Target product profile 
  • Documentation review
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Training and Mentoring
  • Regulatory process
  • Submission content
  • Application maintenance
  • CMC change management

MARKETING AUTHORIZATION SERVICES

RCSS partners with you from planning to submission, delivering tailored regulatory and scientific expertise that maximizes your chances of timely, successful marketing authorization.

Global Marketing Applications
  • Authoring/reviewing  of module 3 and quality overall summary for BLAs/NDAs, MAAs and NDSs 
  • Review full submission
  • Content compliance
  • Responses to Agencies

Marketing Authorization Services

Health Authority Pre-Application Meetings
  • Key questions identification
  • Briefing package preparation/review 
  • Meeting management
  • Minutes preparation
Labeling Preparation
  • Prescribing information 
  • SmPC
  • Product monograph
  • CCDS preparation
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CMC Regulatory/Scientific Support
  • Gap assessment per trial stage
  • Study design (e.g. viral study, stability, process development, validation)​
  • Protocol/report authoring 
  • Deviation investigation
  • Responses to Agencies
Training and Mentoring
  • Submission Content
  • Regulatory approval process
  • Responses to authorities queries

POST-APPROVAL SERVICES

RCSS ensures smooth post-approval operations by guiding lifecycle management, preventing regulatory changes from disrupting your supply chain, and maintaining global compliance.

Post-Approval CMC Change Submissions
  • Reporting category classification 
  • Content plan compliance and completeness
  • Submission authoring/review (e.g.PAS, CBE, Annual report, Type II, IB etc...)
  • Health authority queries management

Post-Approval Services

Post-Approval CMC Change Management
  • Change Control compliance review 
  • Study design
  • Protocol/report authoring/review
  • Comparability protocol
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Training and Mentoring​​
  • Global reporting classification
  • CMC post-approval changes process
  • Submission Content requirements
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