We, Rescisco Global Regulatory consultants, intended to offer quality and regulatory services to the manufacturers of medical devices including in-vitro diagnostic medical devices from conceptualization stage to marketing as per the requirements.
Turnkey Project Consultation
Starting From Zero? We Start With You.
Most regulatory firms step in after the product exists. We step in before it does. Our Turnkey Consultation service is designed for manufacturers, entrepreneurs, and R&D teams who want to build compliance into their product from the very first decision — not bolt it on at the end.
"The most expensive regulatory mistake is the one you made in the design phase that nobody caught until the submission stage. We are the people you call before that mistake can happen."
— Rescisco Global, Turnkey Practice
🗺️ Turnkey Engagement — Phase by Phase
Market Research & Product Feasibility
We analyse the competitive landscape, clinical need, regulatory environment, and commercial potential of your device concept before a single rupee is committed to development. This includes a detailed feasibility report covering intended use, device classification, predicate analysis, and go-to-market pathway.
Detailed Project Report (DPR) Preparation
We prepare bankable DPRs for government grants (BIRAC, DBT, DST, MSME schemes), investor presentations, and internal approvals — incorporating regulatory timelines, testing budgets, facility requirements, and approval milestones.
Facility Design & Layout
We work alongside architects and engineers to design GMP-compliant manufacturing facilities from the ground up — specifying cleanroom classifications (ISO 14644), HVAC design, material flow, and personnel flow based on your product type and regulatory requirements.
Cleanroom Setup & Qualification (IQ/OQ/PQ)
Full cleanroom qualification services including Installation Qualification, Operational Qualification, and Performance Qualification. We ensure your environment meets CDSCO, ISO 13485, and EU GMP requirements before a single component is manufactured.
Intellectual Property Rights Advisory
Regulatory strategy intersects with IP strategy. We help clients understand freedom-to-operate, patentability landscape, and how IP positions can be strengthened through regulatory data exclusivity provisions in key markets.
Product Validation & Verification
We design V&V protocols aligned with design controls requirements, coordinate testing across accredited laboratories, and compile the resulting data into a form acceptable to CDSCO, FDA, and EU reviewers.