Regulatory Support
GxP Cellators: Global Regulatory Affairs & CMC Consulting
Clients benefit from the team’s extensive experience with Health Canada, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) to streamline global regulatory pathways. Regulatory approval is achieved through a clear strategy and an execution-focused plan. The firm provides strategic assessments and practical guidance for global markets, building scalable project models tailored to specific needs and budgets.
The team delivers integrated solutions for international regulatory requirements, clarifying pathways and managing submissions for pharmaceuticals, biologics, and medical devices across North America and Europe. Strategies are based on direct regulatory experience and agency knowledge, providing sponsors with clear guidance on development, Chemistry, Manufacturing, and Controls (CMC), and clinical requirements.
From initial due diligence to post-approval lifecycle management, CMC Regulatory Compliance specialists prepare, review, and file submissions with precision. The team emphasizes proactive problem-solving to help clients achieve and maintain compliance at every stage of the product lifecycle in all major jurisdictions.
Our Global Regulatory & CMC Support Services
Strategic Regulatory Planning & Agency Interactions
Successful market access starts with a well-defined regulatory strategy. The team works with clients to identify the most efficient and low-risk pathway to approval, tailored to each product’s unique characteristics and business objectives.
Special Regulatory Designations
The team identifies and pursues opportunities for expedited development and review to accelerate product timelines.
Orphan Drug Designation (ODD): Preparation and submission of compelling ODD applications to both the FDA and EMA, articulating medical plausibility and prevalence criteria to secure development incentives and market exclusivity.
Pediatric Study Planning: Strategic guidance is provided for developing and negotiating Pediatric Investigation Plans (PIPs) for EMA and Pediatric Study Plans (PSPs) for FDA, ensuring compliance with pediatric regulatory requirements.
Breakthrough / PRIME Designation: Assistance is provided with requests for FDA Breakthrough Therapy Designation or EMA PRIME scheme, highlighting the product’s potential to address unmet medical needs.
FDA Fast Track & Priority Review: Strategic assessment and preparation of requests for Fast Track designation and Priority Review eligibility are offered.
Orphan Drug Designation (ODD): Preparation and submission of compelling ODD applications to both the FDA and EMA, articulating medical plausibility and prevalence criteria to secure development incentives and market exclusivity.
Pediatric Study Planning: Strategic guidance is provided for developing and negotiating Pediatric Investigation Plans (PIPs) for EMA and Pediatric Study Plans (PSPs) for FDA, ensuring compliance with pediatric regulatory requirements.
Breakthrough / PRIME Designation: Assistance is provided with requests for FDA Breakthrough Therapy Designation or EMA PRIME scheme, highlighting the product’s potential to address unmet medical needs.
FDA Fast Track & Priority Review: Strategic assessment and preparation of requests for Fast Track designation and Priority Review eligibility are offered.
Pre-Submission Meeting Preparation
Engaging with health authorities before submission is essential. The team prepares, authors, and strategically plans for meetings with global agencies, including:
Health Canada:Type C and Pre-Submission meetings, including preparation of meeting request packages, briefing documents, and presentation materials.
FDA: Type A, B, and C meetings (Pre-IND, End-of-Phase 2, Pre-NDA/BLA). The team crafts the meeting request, develops the briefing book, and provides coaching for productive discussions.
EMA: Scientific Advice and Protocol Assistance meetings. The team manages the entire process, from drafting the briefing document to coordinating with national authorities and facilitating follow-up responses.
Health Canada:Type C and Pre-Submission meetings, including preparation of meeting request packages, briefing documents, and presentation materials.
FDA: Type A, B, and C meetings (Pre-IND, End-of-Phase 2, Pre-NDA/BLA). The team crafts the meeting request, develops the briefing book, and provides coaching for productive discussions.
EMA: Scientific Advice and Protocol Assistance meetings. The team manages the entire process, from drafting the briefing document to coordinating with national authorities and facilitating follow-up responses.
Global Regulatory Strategy Development
Comprehensive regulatory roadmaps identify optimal submission pathways, target markets, and timelines. These strategies cover the entire product lifecycle, from early development through commercialization and beyond.
Regulatory Intelligence & Horizon Scanning
The team continuously monitors the evolving regulatory landscape, providing proactive updates on new guidelines, emerging expectations, and policy changes that may impact product portfolios across FDA, EMA, and Health Canada.
Clinical Trial Applications (CTA) & Investigational Product Submissions
Initiating clinical trials requires meticulous preparation and submission of comprehensive applications that satisfy the unique requirements of each jurisdiction.
- Health Canada CTA: End-to-end consulting is provided for Clinical Trial Applications (CTA) submissions, including preparation of the application kit, protocol assessment, Investigator’s Brochure review, and ongoing CTA amendments and renewals.
- FDA IND: Comprehensive preparation and management of Investigational New Drug (IND) submissions to the US FDA are provided. This includes authoring the IND in eCTD format, managing annual reports, and preparing responses to FDA clinical holds or information requests.
- EMA CTA & CTIS Submissions: Coordination and preparation of Clinical Trial Applications in accordance with the EU Clinical Trials Regulation (EU CTR 536/2014) and submission via the Clinical Trials Information System (CTIS) are provided. Part I and Part II documentation, timelines, and sponsor interactions are managed by the team.
- Medical Device ITA & IDE:
- Health Canada: Guidance and preparation are provided for Investigational Testing Authorization (ITA) applications for significant risk medical device trials.
- FDA: Preparation and submission of Investigational Device Exemption (IDE) applications for clinical studies, including both feasibility and pivotal trials, are conducted with expertise in FDA IDE regulations (21 CFR Part 812).
- Clinical Trial Application Maintenance: Ongoing support for CTA amendments, protocol deviations reporting, annual progress reports, and end-of-trial notifications across all three jurisdictions.
CMC Due Diligence, Strategy & Compliance
The Chemistry, Manufacturing, and Controls (CMC) section is often the most scrutinized part of any regulatory submission. CMC Regulatory Compliance specialists provide deep scientific and regulatory expertise to ensure that quality packages are robust, coherent, and submission ready.
- CMC Due Diligence & Gap Analysis: Thorough assessment of existing CMC packages against Health Canada, FDA, and EMA expectations is conducted to identify risks, gaps, and opportunities for optimization prior to submission. Analytical methods, manufacturing processes, specifications, and stability data are evaluated to ensure alignment with ICH guidelines and regional expectations.
- Pharmaceutical Development Planning: Strategic guidance is provided on Quality by Design (QbD) initiatives, identification of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), and development of control strategies that support robust manufacturing and regulatory flexibility.
- Regulatory CMC Dossier Preparation & Review: Expert authoring, compilation, and critical review of quality modules are provided across the Common Technical Document (CTD) format.
- Module 3 (Quality): Comprehensive authoring of drug substance and drug product sections for small molecules, biologics (including cell and gene therapies), biosimilars, and natural health products.
- Master Files: Preparation and maintenance of Drug Master Files (DMFs) for FDA (Type II, III, IV), Active Substance Master Files (ASMFs) for Europe, and equivalent filings for Health Canada are provided.
- BLA/NDA/ANDS Readiness: The CMC section of marketing applications is ensured to be complete, consistent, and compliant with regional eCTD specifications and agency-specific expectations.
- Investigational Medicinal Product Dossier (IMPD): Authoring of IMPDs for European clinical trial applications is conducted, ensuring alignment with the quality requirements of the EU CTR and preparedness for potential inspections.
- Response Management: Rapid and effective preparation of responses to Health Authority questions and deficiency letters. Our specialists craft scientifically sound, clearly justified arguments to facilitate the swift resolution of queries and to move your application forward.
- Supplier& CMO Qualification Support: Assistance is provided with the selection, technical assessment, and qualification of third-party manufacturers and suppliers. Gap analyses are conducted, and remediation support is offered to ensure CMOs meet global GMP and regulatory expectations.
Post-Approval CMC & Lifecycle Management
Maintaining compliance after approval requires vigilant management of changes and ongoing regulatory obligations. Strategic and operational support is provided to ensure that products remain compliant throughout their lifecycle.
- Post-Approval Change Management: Strategic assessment and execution of post-approval changes are provided, including manufacturing site transfers, process improvements, specification updates, and container closure system changes.
- FDA: Preparation and submission of Prior Approval Supplements (PAS), Changes Being Effected (CBE-30 and CBE-0), and Annual Reportable changes.
- EMA: Management of Type IA, Type IB, and Type II Variation submissions, including coordination across affected member states where applicable
- Health Canada: Preparation and submission of Post-DIN Changes (Quality, Safety, and Efficacy submissions), including Notifiable Changes (NCs) and Supplement to a DIN Submission (SDS).
- Lifecycle Maintenance Submissions: Preparation and submission of annual reports, renewals, and other periodic updates are provided.
- FDA Annual Reports: For NDAs, BLAs, and ANDAs, summarizing changes, new data, and stability commitments.
- EMA Renewals: Management of the marketing authorization renewal process, including preparation of renewal applications and coordination with reference member states.
- Health Canada Annual Reviews: Integration with Product Quality Reviews (PQRs) and annual compliance reporting.
- Stability Program Oversight: Design and management of stability studies are provided to support shelf-life extensions, post-approval changes, and ongoing commitment batches. Oversight of protocol development, data review, and statistical analysis is conducted to ensure compliance with ICH Q1A/E requirements.
- Commitment Tracking & Management: Systematic tracking and execution of post-marketing commitments and requirements are provided, ensuring timely fulfillment and regulatory reporting to avoid compliance issues.
Product Registration & Market Access
Achieving marketing authorization is the gateway to commercial success. Guidance is provided through complex registration processes for pharmaceuticals, biologics, and medical devices.
- Pharmaceuticals & Biologics Registration:
- FDA: New Drug Applications (NDA), Biologics License Applications (BLA), and Abbreviated New Drug Applications (ANDA). End-to-end support is provided, from pre-submission meetings to final approval.
- EMA: Marketing Authorization Applications (MAA) via Centralized, Decentralized (DCP), or Mutual Recognition (MRP) Procedures. Guidance is provided on procedure selection, rapporteur choice, and the entire assessment process.
- Health Canada: New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS), and Supplemental Submissions (SNDS). The team possesses deep expertise in Health Canada’s submission requirements and review processes.
- Natural Health Products (NHPs): Preparation and submission of NHP Product License Applications, including evidence summaries, quality documentation, and label reviews in compliance with the Natural Health Products Regulations.
- Medical Device Registration:
- FDA: 510(k) Pre-market Notification, De Novo requests, and Premarket Approval (PMA) applications. Assistance is provided with device classification, substantial equivalence arguments, and clinical data summaries.
- Health Canada: Registration of Class I-IV medical devices, including Medical Device Licence (MDL) applications for Class II-IV devices and Medical Device Establishment Licence (MDEL) applications for Class I importers/distributors.
- EU MDR/IVDR: Preparation of Technical Documentation for CE Marking under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) is provided. Assistance is offered with classification, selecting the conformity assessment route, and interacting with Notified Bodies.
- OTC & Cosmetics: Regulatory classification, monograph compliance assessments, and label reviews for over-the-counter drug products and cosmetics, including Drug Identification Number (DIN) applications and cosmetic notifications.
- Labelling & Artwork Development: Pre-approval and post-approval label reviews are conducted to ensure compliance with regional requirements for product cartons, inserts, package inserts, and Product Monographs. Support is provided to maximize claims while maintaining regulatory alignment.
Pharmacovigilance & Post-Market Surveillance
Ensuring patient safety and compliance with pharmacovigilance (PV) obligations is critical throughout the product lifecycle.
- PV System Establishment: Design and implementation of pharmacovigilance systems are provided to meet global requirements, including appointment of an EU Qualified Person for Pharmacovigilance (QPPV) and a US FDA Pharmacovigilance Responsible Person.
- Pharmacovigilance System Master File (PSMF): Authoring and maintenance of the PSMF for EU compliance, ensuring it accurately reflects the PV system and is inspection ready.
- Risk Management Plans (RMP): Development of EU RMPs and FDA Risk Evaluation and Mitigation Strategies (REMS), including safety specification, pharmacovigilance plan, and risk minimization measures.
- Adverse Event Management: Procedures are established for adverse event collection, processing, evaluation, and expedited reporting to health authorities (e.g., FDA MedWatch, Health Canada Vigilance, Surveillance).
- Periodic Reports: Preparation of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Annual Summary Reports (ASRs) is provided in compliance with ICH E2C(R2) and regional requirements.
- Signal Detection & Management: Signal detection activities are implemented, including literature scanning, data mining, and trend analysis, to identify and evaluate emerging safety signals.
Quality Systems & Compliance
Robust quality systems underpin regulatory success. Comprehensive support is provided to establish, maintain, and continuously improve quality and compliance posture.
- Quality Management System (QMS) Design: Development and implementation of GMP, GLP, GCP, and GDP-compliant quality systems, including policies, procedures, and work instructions tailored to your organizational structure.
- Inspection Readiness & Hosting: Comprehensive preparation for health authority inspections is provided, including mock inspections, staff training, and document organization. Real-time support is available during FDA, Health Canada, and EMA inspections, including scribe services and response management.
- Audit Support: Third-party audit services for suppliers, CMOs, and internal operations. We conduct gap analyses and provide remediation guidance to ensure compliance with global GMP, GLP, and GDP standards.
- Deviation, CAPA, and Change Control: Design and optimization of quality processes for deviation management, root cause analysis, CAPA implementation, and change control to ensure effective issue resolution and continuous improvement.
- Product Quality Review (PQR): Preparation and review of annual Product Quality Reviews (PQRs/APQRs) are provided, including analysis of quality trends and identification of opportunities for process and product improvement.
- Recall Management: Development of recall procedures and management of product recall activities are provided, including health hazard evaluations, recall strategy, and communication with health authorities and customers.
Reach Out to Us!
For more details or to discuss your project requirements, please reach out to us. Your query will be handled with complete confidentiality, and we’ll ensure a prompt response.
