Global Regulatory Affairs Expertise — Dysmech Clinical Services (DCS)
Dysmech Clinical Services (DCS) provides advanced global regulatory consulting supported by deep expertise in major health authority frameworks, including CDSCO (India), EMA (Europe), USFDA (USA), MHLW (Japan) and other international agencies.
With strong regulatory intelligence, technology-driven systems, and highly experienced consultants, DCS helps organizations navigate complex global requirements with precision, efficiency, and full compliance.
As global clinical trial regulations evolve rapidly, DCS ensures your submissions, dossier formats, documentation, and clinical strategies stay aligned with the latest worldwide standards.
Global Regulatory Authorities We Support
🇮🇳 India
CDSCO — Central Drugs Standard Control Organization
International Bodies
ICH — International Council for Harmonisation
WHO — World Health Organization
WTO — World Trade Organization
🇪🇺 Europe
EMA — European Medicines Agency
🇺🇸 United States
- USFDA — Food & Drug Administration
- DHHS — Department of Health & Human Services
- NCCAM — Complementary & Alternative Medicine Authority
🇯🇵 Japan
MHLW — Ministry of Health, Labour and Welfare
🇬🇧 United Kingdom
MHRA — Medicines & Healthcare Products Regulatory Agency
🇦🇺 Australia
TGA — Therapeutic Goods Administration
🇨🇳 China
SFDA — State Food & Drug Administration
🇧🇷 Brazil
ANVISA — National Health Surveillance Agency
🇳🇿 New Zealand
Medsafe — Medicines & Medical Devices Safety Authority
Current Regulatory Trends & Amendments (India & Global)
🇮🇳 India — NDCT Rule Amendments (2024–2025)
Mandatory CRO Registration
- India now formally defines Clinical Research Organisations (CROs).
- All CROs must register with CDSCO/DCGI to conduct:
- Human clinical trials
- BA/BE studies
CRO operations without registration are no longer permitted
Ease-of-Doing-Business Reforms
- Test licenses moving to an intimation/notification-based
- Processing timelines reduced from 90 days → 45 days.
- Low-risk BA/BE studies may start with notification (exceptions include hormones, psychotropics, etc.).
Waiver of Local Clinical Trials
Applicable to drugs already approved in US, EU, UK, Japan, Australia, Canada for:
- Orphan drugs
- Gene & cell therapies
- Pandemic/Defense drugs
- Innovative therapies addressing unmet needs
👉 Many require Phase 4 post-marketing studies in India.
Faster Approvals & Deemed Approval
- Domestic trial approvals: 30 working days
- Global trials: 90 working days
- If CDSCO does not respond within the stipulated period → approval may be deemed granted.
Compensation & Post-Trial Access
- Schedule VII outlines clearer injury/death compensation formulas.
- Sponsors may need to provide the investigational drug post-trial if the patient benefits and no alternatives exist.
Pediatric Development & Ethics Updates
- Greater focus on pediatric development plans aligned with EMA/FDA standards.
- Stronger governance for Ethics Committees.
- New SOPs for CROs, investigators, and trial sites under development.
Global Regulatory Trends & Updates
ICH E6(R3) — Modernized GCP
- Stronger digital data integrity requirements
- Framework for decentralized trials
- Enhanced risk-based monitoring
- Increased sponsor accountability
ICH E20 — Adaptive Clinical Trials
- Supports adaptive confirmatory designs such as:
- Early stopping
- Sample size adjustments
- Population adaptations
- Improves efficiency and flexibility in global trials.
EMA — ATMP & CTIS Evolution
- Expanded requirements for gene therapy, cell therapy, and ATMP trials.
- CTIS mandates stricter transparency and faster reporting.
Global Transparency & Registration Rules
- Mandatory trial registration and timely publication of results.
- Reinforced through EMA Q&A and Declaration of Helsinki
Japan PMDA — Pediatric Guidance
- New 2024–2025 expectations increase obligations for pediatric development plans (PDDs).
Aligns Japan closer to EMA/FDA pediatric frameworks.
Understanding Pharmacovigilance
DCS offers complete global Regulatory Affairs support, ensuring compliance, accelerated approvals, and reduced regulatory risk.
✔ Global Regulatory Lead Support
Leadership for multinational regulatory strategies and lifecycle management.
✔ Submission Planning & Content Strategy
Region-specific dossier development (CTD/eCTD), content mapping, and submission readiness.
✔ Regulatory Affairs & CMC Support
- Labeling & packaging compliance
- Local trial requirements
- Approval contingency planning
- Climatic zone stability strategies
- Country-specific document formats
- Sample/QC documentation
- Product launch regulatory planning
✔ Scientific Advice & Authority Interactions
Full support for meetings with CDSCO, EMA, FDA, MHRA, PMDA, and other agencies.
✔ Submission Gap Analysis
Detailed compliance review of CTD modules, technical reports, and supporting documents.
✔ Regulatory Mergers & Acquisitions
Regulatory due diligence, risk assessment, and portfolio evaluation.
✔ Pediatric Development & PIPs
Support for pediatric plans required by EMA, FDA, and PMDA.
✔ Implementation of New Guidelines
Expertise across evolving frameworks such as:
- ICH Q3D (Elemental Impurities)
- ICH Q12 (Product Lifecycle Management)
- QbD (Quality by Design)
- Updated CDSCO/EMA/FDA/PMDA guidance
Why Regulation Matters
Quality
Safety
