Comprehensive Regulatory Solutions at Your Service
Leveraging extensive sector expertise, end to end Regulatory services for faster product approvals and life cycle management of products for Pharmaceutical products, Biological products and Medical devices across global markets.
We provides fast-track support, response within 24 – 48 hours and strategy-led regulatory execution—done right the first time.
Regulatory Services
We provide end-to-end regulatory consulting for pharmaceutical products, Biological products and medical devices, including submission strategy and dossier preparation, health authority support, and compliance services such as gap analysis, nitrosamine guidance, due diligence, and remediation to improve approvability and market expansion
LABELING SERVICES AND ARTWORK MANAGEMENT
We manage comprehensive regulatory labeling and artwork management for pharma products across the US, Canada, and Europe, including SPL submissions, packaging artwork lifecycle control, proofreading/quality checks, and promotional material label review
Merger and acquisition facilitation services
We support mergers and acquisitions with regulatory transition assistance, project management, and strategic consulting to ensure a smooth application handover
post-approval change management system
We manage post-approval regulatory changes, including supplements and variations, annual reports and renewals, change control, and PADER/safety report submissions
Publishing and submissions
We provide global regulatory publishing and submissions support, including eCTD filings, SPL submissions, and self-identification, BNCC, and establishment registration.
headhunting
We provide temporary staffing or contract staffing of highly specialized professionals for project-based, interim, or short-term roles.
Technical-scientific translation
We provide accurate technical-scientific translations, delivering high-quality Spanish and Russian language translations.
