Regulatory Affairs Services

We support companies in navigating the complex and evolving regulatory frameworks in the U.S., EU, and ROW markets. Our regulatory experts ensure your product reaches the market efficiently and remains compliant post-approval.

Regulatory Capabilities:

Pre-Submission Strategy & Guidance

Regulatory pathway assessment (NDA, ANDA, IND, BLA, PMA, 510(k))

Interactions with health authorities – Pre-IND, End-of-Phase 2 meetings

Briefing document preparation and regulatory roadmap development

Dossier Compilation & eCTD Publishing

Preparation of CTD modules 1–5 including clinical summaries, CMC, and safety documentation

Regulatory publishing in eCTD/NeeS formats using tools like Extedo, Lorenz, GlobalSubmit

Lifecycle maintenance (amendments, variations, annual reports)

Post-Market Compliance

Labeling updates, promotional material review, controlled correspondence

Risk evaluation and mitigation strategies (REMS, RMPs)

CMC change submissions and site transfers

Medical Device Regulatory Support

EU MDR and IVDR compliance, UDI registration

Technical file and design dossier preparation

Submission pathways: FDA 510(k), PMA, De Novo applications