Regulatory Consulting
Core Services
1. Regulatory Strategy & Global Submissions
* Market Entry Planning: Develop optimized regulatory pathways for FDA
(U.S.), EMA (EU), CDSCO (India), TGA (Australia), and other national health
authorities.
Submission Management: Author, compile, and submit CTDs, eCTDs, 510(k)s,
PMAs, CE Marking dossiers, and other region-specific filings.
Health Authority Liaison: Facilitate pre-submission meetings, scientific
advice procedures, and negotiations with agencies (e.g., FDA pre-IND, EMA
Scientific Advice).
2. Product Lifecycle Management
* Pre-Approval: Regulatory support for clinical trial applications
(IND/IMPD), orphan drug designations, and expedited programs.
Post-Approval: Variations, renewals, labelling updates, and PSUR/PBRER
submissions.
Medical Device & IVD Compliance: Full-cycle support for FDA 21 CFR 820, EU
MDR/IVDR, ISO 13485, and global device registrations.
3. Compliance & Quality Assurance
* GxP Audits & Remediation: Conduct gap analyses, prepare for FDA/EMA
inspections, and address findings (e.g., FDA Form 483, EU Non-Compliance
Reports).
Computer System Validation (CSV): Implement and validate software systems
per FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Quality Management Systems (QMS): Design and optimize SOPs for GMP, GLP, and
GDP compliance.
4. Drug Development & Technical Support
* CMC Regulatory Strategy: Align formulation, manufacturing, and analytical
development with ICH guidelines (Q8-Q11).
Biologics & Advanced Therapies: Navigate complex requirements for biologics,
biosimilars, cell/gene therapies, and ATMPs.
5. Post-Market Surveillance & Risk Management
Pharmacovigilance: Implement adverse event reporting systems (e.g.,
EudraVigilance, FDA MedWatch).
Risk Evaluation & Mitigation Strategies (REMS): Design and execute
post-approval safety protocols.
