Regulatory Affairs

We can help achieve your objectives with our consultative approach and comprehensive oversight of activity throughout the approval cycle. Our team comprises CMC professionals skilled in the preparation, compilation, and delivery of regulatory submissions. We bring together knowledge and skill, ensuring accuracy, accountability, and responsiveness throughout the entire regulatory cycle. Our CMC experts have extensive knowledge in combining scientific guidelines with regulatory guidelines to prepare the most appropriate M1, M2.3 and M3 sections for initial marketing authorization applications and product lifecycle management submissions.

• Prepare and review IND, NDA, ANDA, ANDs, NHP, IMPD, Initial MAA via MRP/DCP, and national procedure for EU and other similar regional dossiers, including Eurasian Economic Union (EAEU), APAC, Middle East, LATAM, and African Markets (AfME)
• Prepare and review DMF/ ASMF for the US FDA and EU Directorate for the Quality of Medicines (EDQM) requirements
• CMC regulatory gap analysis for identification, assessment, and provision of CMC regulatory mitigation strategies for remediation
• Conversion of legacy dossiers to current CTD requirements, including module one requirements
• Prepare normative documents for EAEU countries
• Prepare CMC responses to health authorities’ questions
• Marketing authorization transfer (MAT), legal category switch (e.g., Rx to OTC), and line extensions of existing product registrations
• Prepare harmonized dossiers for submission across multiple countries for global market expansion
• Correspondence with health authorities
• Support reformulation of existing products for submission to global regulatory agencies

Ensuring compliance throughout the product lifecycle is of paramount importance for a marketing authorization holder. Each health authority has its own requirements for post-approval maintenance. Tracking and managing post-approval commitments might be challenging, considering the ever-changing regulatory landscape. ClinChoice, with its expert regulatory team, has extensive experience in providing customized regulatory services for the lifecycle management of marketed products.

• Develop regulatory post-approval filing strategies and variations for global products
• Manage post-approval changes for products manufactured in-house and by contract manufacturers
• Planning, creation, evaluation, execution, monitoring, and implementation of proposed changes through change control management
• Perform regulatory assessment for the proposed changes to evaluate the submission strategies and timeline
• Preparation and review of variation package for administrative, labeling, quality, and safety changes for global markets
• Tracking of PSUR/PBRER, annual report, and renewal submission calendar
• Preparation and review of annual reports and submission to FDA for drug substances and drug product
• Preparation and review of renewal packages for EU and non-EU countries
• Responding to RFIs from health authorities, ensuring quicker approval
• Prepare amendments and supplement the submission package
• Prepare and update Product Quality Reviews (PQRs) and Annual Product Reviews (APRs)
• Communicate regulatory status changes to cross-functional teams for implementation
• Product registration support for country-specific legal documents
• Health authority website updates for product information post-approval

ClinChoice submission management experts offer a wide range of services that impart intelligence into service delivery to reduce the operational cost significantly and aid quicker approval of submissions, ensuring speedy access to the market. Our experience involves dossier planning, coordination, execution, managing document retrieval, delivering registration dossiers, notifying data management teams regarding the status of the submission, and updating document status in the document management system.

• Coordination of the writing, review, strategy discussions, publishing, and application for lifecycle maintenance activities
• Provide guidance on regulations and submissions related to registration requirements and regulatory intelligence
• Creating and maintaining a knowledge repository for regional requirements across the globe
• Chair meetings between client stakeholder teams, discuss submission-related topics, and create and share meeting minutes
• Assist the client team in preparing a forecast of upcoming submissions and keeping the respective team members informed
• Provide weekly status updates to the client team on submission progress
• Resolve issues or escalation in coordination with the client team
• Identify any risks or threats to the project and provide a mitigation strategy
• Maintain product lifecycle trackers, renewal trackers, variation history trackers, post-approval commitment trackers, etc., which were controlled through the version numbers

ClinChoice helps biopharmaceutical companies prepare and manage global and local company core data sheets (CCDSs). Our team has proven experience in centrally managing the entire label lifecycle, from initial design and review to obsolescence. After the product launches, each CCDS must be updated to reflect the product’s evolution, revealing new indications, safety concerns, and changes in dosage, administration, and handling procedures.

• Development and maintenance of Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI), and Reference Safety Information (RSI).
• Chair CCDS core team meetings and monitor and track the progress of each CCDS
• Coordinate with cross-functional teams for collating supporting documentation like clinical overview
• Review and finalization of CCDS, including literature references, citations, and formatting checks
• Update regional labeling information in reference to the updated CCDS and coordinate with the local regulatory team for variation submissions
• Monitor and track implementation of CCDS changes within local product information
• Tracking of CCDS lifecycle and deviations

Our local and global labeling hubs create and maintain labels and artwork with unparalleled market intelligence, deep domain expertise, and extensive product knowledge . ClinChoice is a one-stop solution for artwork creation, design, proofreading, and proofreading of labels that comply with regulatory requirements to provide clear and accurate information to healthcare professionals, patients, or end users.

• Create Summary Product Characteristics (SPC) and Patient Information Leaflet (PIL)
• Drafting structured product labeling
• Perform manual (character-by-character) and electronic proofreading
• Verification of artwork compliance with regulatory guidelines
• Review of advertisements, educational, and promotional materials
• Global change control management, which includes tracking and implementing changes in local labels
• Perform side-by-side label comparison (image-to-image comparison)
• Design artwork and labels based on marketing and regulatory requirements
• Provide project management for end-to-end labeling management
• Interact with cross-functional teams and printing labs to ensure project accuracy, compliance, and timeliness, including reviewing print proofs from third-party vendors
• Quality check and verification
• Suitability and accuracy check for the product information on artwork in reference to approved source documents
• Gap analyses between distributed and submitted labels
• Expertise in designing artwork with Adobe Illustrator, InDesign, and Photoshop to create pharmaceutical product artwork designs

ClinChoice manages the creation, preparation, and submission of drug listings to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FD&C), which requires firms that manufacture, prepare, propagate, compound, or process drugs in the US or that are offered for import in the US to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA. Drug Listing is an electronic submission in Structured Product Labeling (SPL) format as required by the FDA, and it’s submitted through the FDA’s gateway.

• Evaluate and assign the National Drug Code (NDC) to bulk and finished products
• Support electronic listing of new drugs, changes, and de-listings on the FDA website
• Provide technical support for high-quality regulatory submissions related to product launches, updates, and lifecycle management
• Author and review documents for submission (SPL, ESG FDA receipt, DailyMed)
• Change Control evaluation and approval related to drug listing updates
• Compile, route, and upload information into internal databases
• Support document updates (SOP, CAPA, corrections)
• Support blanket no changes certification of product listing
• Support annual product and establishment registrations

ClinChoice navigates the regulatory impact on products in mergers and acquisitions (M&As) , ensuring compliance throughout the transition. Our expertise in managing large-scale pharmaceutical entity integrations helps you achieve organizational goals. We understand the relationship between regulatory and compliance requirements and the M&A process. We can support legal entity consolidation goals by strategically integrating the marketing interests of holding authorities with necessary regulatory compliance.

• Analyses of impacted marketing authorizations, including all product SKUs
• Identification of country-wise regulatory documentation
• Preparation of documents and samples for marketing authorization transfers, including administrative papers and GMP certificates
• Facilitating notarizations and legalizations/apostilles with relevant embassies or consulates
• Regulatory updates resulting from the change of QPPV for impacted marketing authorizations
• Leading discussions with cross-functional teams to review the impact of the change control and seek approval
• Response to question from health authorities
• Implementation of the change after approval from HA
• Manage the agreed transition period with HA for using the old artwork to ensure compliance with the agreed terms and conditions
• Educate cross-functional teams on the transition period (during which the existing artworks can be used based on the agreed timeline with HA) and accordingly plan the future procurement of artwork materials
• Initiate change control for labels and artworks in scope to reflect the new legal entity
• Implementation of the change in the local labels

ClinChoice manages global and local regulatory information with expert technology prowess and the best data management practices. Our team provides comprehensive data maintenance support in the Regulatory Information Management System (RIMS), ensuring prompt application submissions, approvals, and renewals. We facilitate the drug registration process, offering visibility, timely submissions, responses, and immediate access to regulatory information and documents. It enables the development of short- and long-term strategies, meeting submission timelines with minimal impact on day-to-day operations.

• Create new license entries or make required data updates to the existing licenses by referring requests at the drug product and product registration level
• Create and maintain activities for drug product variations, license renewal, MAH transfer, and license withdrawal
• Perform data clean-up, data coordination, and maintenance activity to ensure data across all regions are consistent and error-free
• Maintain the additional data required for xEVMPD in EEA countries and perform xEVMPD data submission to EMA directly using the RIMS
• Perform xEVMPD data submission manually in EVWEB for specific scenarios
• Complete bulk license record changes from local RA affiliates, product owners, and project sponsors
• Provide technical support in testing the new RIMS application and perform data migration to the latest software
• Conduct gap analyses on regulatory data in reference to IDMP ISO standards/elements: ISO 11238, ISO 11239, ISO 11240, ISO 11616, and ISO 11615
  • Gather necessary data from diverse sources and consolidate it into a standardized IDMP template
  • Offer assistance for vendor analysis to streamline the finalization of the IDMP tool, facilitating the smooth migration of data into the IDMP tool

ClinChoice efficiently manages regulatory documents to expedite dossier compilation and compliance. We maintain the regulatory document repository for dossiers, labeling, variation and renewal files, correspondences, PSURs, and pharmacovigilance documents for all products. Our Document Management System (DMS) specialists lead implementation and provide training to ensure compliance.

• 21 CFR Part 11 compliance and maintenance
• Installation and operational qualification documentation
• Required technical support for implementation
• Training schedule and content development
• Electronic data mapping documentation
• Electronic data re-arrangement
• Paper scan data migration to DMS
• Liaison with country affiliates

ClinChoice supports the creation of legal and non-legal documents for new registrations, renewals, tender participation, and technology transfer, among other requirements, drawing on our team’s extensive knowledge of regulatory requirements in mature and developing markets.

• Legal document preparation and review for LOA, POA, LOD, undertaking declarations, formula pages, one group certificates, manufacturing agreements, QA certificates, BSE, GMP, FDA print screen, third-party attestations, explanation letters, and ISO certificate s
• Cross-functional team coordination
• Work instruction and template maintenance
• Finished product samples, reference standards, and APIs
• Legalization management through consular services
• Regulatory request processing
• Ad-hoc regional ancillary documentation
• Product portfolio support

ClinChoice has a robust intelligence-gathering framework that leverages its diversity to remain fully informed about changes worldwide. Our regulatory intelligence service team is comprised of pharmaceutical experts from the industry who collect and evaluate regulatory information by monitoring the current regulatory environment and generating comprehensive and advanced regulatory strategies to obtain and maintain product approvals in a timely and competent manner.

• Review and collect the information from health authority websites like the US FDA, Canada, EMA, CMDH, HMA, PRAC and other global health authority websites
• Analyze the collected data and categorize the information on an impact basis to advise clients on the regulatory requirements for both content and format
• Track down the meetings and reports of committees such as PRAC, CMDH, CHMP, and others to understand the root cause of the recommendation to analyze the impact of the outcomes
• Classify the updates based on the time given for implementation and accordingly prepare assessment reports
• Customized intelligence reports based on client requirements focused on CMC, quality, labeling, packaging, and others.
• Global and local impact analysis of new regulations
• Product categorization and classification
• Product registration and update requirements
• Monitoring and tracking of implementation of new updates on impacted products and processes
• Closure of impact assessment post-implementation
• High alert notification for urgent safety updates