Our team can help achieve your objectives with our consultative approach and comprehensive oversight of activity throughout the approval cycle. We strive to exceed your expectations in terms of:
- Compliance
- Quality
- Timeliness
Our team is comprised of expert CMC professionals, experienced and skilled in the preparation, compilation, and delivery of regulatory submissions. Our team brings together the knowledge, skill, and expertise, ensuring accuracy, accountability, and responsiveness throughout the entire regulatory cycle.
Our services include:
- Regulatory consulting for strategy and desired pathway for submission
- Interaction with health authority for the pre-submission discussion
- Pre-approval assistance
- Post-marketing change management
- Product lifecycle management
- Response to health authority questions
- Market Intelligence and Strategy
Pre-approval assistance:
- Compile dossiers per US FDA requirements for Investigational New Drug (IND), New Drug Application (NDA), Biologics License Application (BLA), and Abbreviated New Drug Application (ANDA)
- Compile dossiers per EU legislation for Marketing Authorization Application (MAA) via Centralized Procedure (CP), National Procedure (NA), Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP), and Repeat Use Procedure (RUP)
- Prepare bibliographic and line extension applications for EU regions
- Compile dossiers for Latin America (LATAM), CIS, CAR, Africa, Middle East, GCC, and Asia Pacific (APAC) per regulatory guidelines, including direct submissions for various agencies
- CMC regulatory gap analysis for identification, assessment, and provision of CMC regulatory mitigation strategies for remediation
- Authoring of Drug Master File/Active Substance Master File
- Multilingual submissions for local registrations
- Consultation and response to questions from agencies
- Scientific interpretation of regional guidelines
- Converting legacy paper dossiers to CTD format by providing scientific guidance to generate additional required documentation
- Prepare product information (SmPC/PL/Label), PIF and mock-ups
Post-marketing assistance/Product lifecycle Management
- Preparation of, and assistance with, submission of amendments, supplements, and variations to marketing authorizations
- Authoring of annual reports, supplements, and amendments for IND, BLA, NDA and ANDA
- Review of changes to advertising and promotional materials
- Renewal of licenses for the Rest of World (ROW) countries
- Prepare and finalize renewal submission package for all procedures in EU (CP/NA/MRP/DCP/RUP)
- Respond within stipulated timelines on queries/deficiencies raised by health authorities and customers
- Reformulation for submission to global regulatory agencies, including raw material assessments, ingredient list generation, toxicity testing, labeling, dossier preparation, and registration
- Evaluation of change control for the region-wise impact
- Creation and review of change control request
- Product quality review and annual product review
- Global Change Control Management and tracking
Support for Medical Devices Lifecycle Management
- Support for medical device development, including assistance in 510(K), pre-market approval (PMA), and de novo submissions to FDA
- Advice on EU directives to achieve compliant CE marking
- Eligible to act as the regulatory authorized representative for non-EU manufacturers without an office in an EU member state
- Assign Unique Device Identification (UDI) numbers for medical devices