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.
​
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.
​​​​
Explore how RCSS can support and guide you through each phase of your drug development by navigating the stages below.​​
CLINICAL 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 across the U.S., EU, Canadian, and Israeli markets to ensure strategic and compliant development.
Clinical development services at RCSS include:​​​​
➤ Defining the regulatory path – Establishing a clear, stepwise development strategy tailored to your product and target markets, including regulatory pathways such as 505(b)(1) NDAs, BLA under PHS Act 351 (a), and expedited programs like Orphan Drug and Fast Track designation.
➤ Support clinical development and clinical trial design – Advising on trial methodology, endpoints, patient populations, and regulatory alignment, while offering strategic input to optimize the trial design to support the intended indication and align with the Target Product Profile (TPP).
➤ Design, review, and authoring of CMC studies – Advising on, evaluating, and authoring protocols and reports for a wide variety of CMC studies—from simple stability studies to complex viral clearance studies—required at various clinical development stages to ensure compliance with regulatory expectations and support product quality and safety.
➤ Data requirements and gap assessment – Defining and evaluating the readiness and adequacy of non-clinical, CMC, and clinical data required to support applications at your specific clinical development stage.
➤ Leading health authority consultations during clinical development – Managing interactions with health authorities (HAs), including FDA meetings (pre-IND, EOP II, Type A, C, or D), EU scientific advice meetings, and pre-CTA meetings with Health Canada. Activities include formulating key questions, authoring/reviewing briefing packages, and preparing presentation materials. These consultations aim to align development plans with regulatory expectations and support a more efficient and informed review of upcoming clinical trial applications.
➤ Review of clinical documentation – Reviewing clinical protocols, investigator brochures (IBs), informed consent forms (ICFs), clinical study reports (CSRs), and other essential documents to ensure consistency with trial objectives, compliance with regulatory requirements, and alignment with the intended indication.
➤ Authoring/reviewing clinical trial applications (CTAs/INDs) – Preparing and reviewing key regulatory components of clinical trial applications, with a particular focus on CMC sections. This includes ensuring data consistency, regulatory compliance, and alignment with regional requirements (e.g., FDA, EMA, Health Canada, Israeli MOH) to support timely and successful trial initiation.
➤ Health Authority CMC queries management – Leading the preparation of scientifically sound and regulatory-compliant responses to CMC queries raised during the review of clinical trial applications, ensuring timely resolution and supporting the advancement of your clinical program.
➤ Maintaining regulatory applications – Supporting ongoing obligations such as annual reports, and amendments to ensure compliance throughout the clinical program.
➤ Leading quality-related deviation management – Driving comprehensive investigations into quality-related deviations with a deep scientific approach. This includes conducting root cause analyses, performing thorough impact assessments, and authoring robust regulatory justifications to ensure compliance and support uninterrupted product development.
➤ Training and mentoring on regulatory, GMP, and Change Control Process (CCP) – Providing tailored training and mentoring for teams on regulatory frameworks, Good Manufacturing Practice (GMP) requirements, and effective management of the Change Control Process (CCP) related to clinical trial materials. Empowering teams with the knowledge and best practices necessary to ensure compliance, quality, and smooth execution throughout the clinical development process.
MARKETING AUTHORIZATION SERVICES
RCSS supports marketing authorization applications to FDA (BLA, NDA), EMA (MAA) and Health Canada (NDS).
​
Marketing authorization services at RCSS include:​​​​​​​​​​​​​​​​​
➤ Data requirements and gap assessment – Defining and evaluating the readiness and adequacy of non-clinical, CMC, and clinical data required to support marketing authorization applications, in light of applicable regulatory requirements, product-specific development history, and prior health authority feedback received during clinical development.
➤ Design, review, and authoring of CMC studies – Advising on, evaluating, and authoring protocols and reports for a broad range of CMC studies—from basic stability testing to complex viral clearance to complex process validation studies—required to support marketing authorization applications, ensuring compliance with regulatory expectations and demonstrating product quality, safety, and readiness for commercialization.
➤ Leading Health Authority consultations prior to submission – Managing interactions with health authorities (HAs), including FDA pre-BLA/pre-NDA meetings, EMA pre-submission meetings, and Health Canada pre-NDS consultations. Activities include formulating key questions, authoring/reviewing briefing packages, and preparing presentation materials. These consultations aim to present the pivotal clinical data intended to support marketing authorization, gain alignment on its adequacy for licensure, and allow final discussion of key CMC and non-clinical aspects of the submission.
➤ Authoring and review of Module 3 and Quality Overall Summary (QoS) – Ensuring data consistency, regulatory compliance, and alignment with regional requirements (e.g., FDA, EMA, Health Canada, Israeli MOH) to effectively support the review and approval of marketing authorization applications.​
➤ Health Authority CMC queries management – Leading the preparation of scientifically robust and regulatory-compliant responses to CMC questions raised during the review of marketing authorization applications, ensuring timely resolution and supporting the path to product approval.​
➤ ​Labeling strategy, authoring, and review – Providing expert support in the development, authoring, and review of regulatory labeling documents, including FDA Prescribing Information (PI), EU Summary of Product Characteristics (SmPC), and Canadian Product Monograph (PM). This service also covers the preparation and maintenance of core labeling documents such as the Company Core Data Sheet (CCDS) and Company Core Safety Information (CCSI), ensuring consistency, regulatory compliance, and alignment across global markets.
POST-APPROVAL SUBMISSIONS SERVICES
Following product approval, it is essential to manage changes in compliance with regulatory requirements, while ensuring proactive planning to avoid supply chain disruptions.
​
Post-approval services at RCSS include:​​​​​​​​​​
➤ Change control and comparability protocols – Providing strategic regulatory support and documentation for post-approval CMC changes (e.g., manufacturing process, analytical method, or critical reagent changes). This includes supporting change control processes, authoring/reviewing comparability protocols, and preparing data packages that demonstrate maintained product quality, safety, and efficacy. Activities also involve coordinating risk assessments and ensuring cross-functional alignment to secure timely approvals, strong scientific justification, and prevention of supply disruptions.
➤ Authoring and review of post-approval CMC change submissions – Preparing and reviewing regulatory submissions to support CMC changes after approval. This includes FDA reporting categories (e.g., Prior Approval Supplements [PAS], CBE-30, and Annual Reports), EU variation types (Type IA, IB, and II), and all corresponding levels of changes submitted to Health Canada. Submissions are tailored to ensure compliance, efficient review, and continued product availability.
➤ Labeling updates – Authoring or reviewing updates to product labeling and prescribing information in line with new data or evolving regulatory requirements.
➤ ​Regulatory intelligence and compliance monitoring – Providing ongoing surveillance and interpretation of changes in regulatory guidelines that may impact marketed products.
➤ ​Regulatory training and mentoring – Delivering training on post-approval compliance, submission requirements, and reporting categories to strengthen internal team capabilities.​