Beyond core regulatory submissions, manufacturers need a suite of ancillary compliance services to operate legally and sustainably. We provide these as standalone services or as part of an integrated programme.
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DSIR — Scientific & Industrial Research
Recognition applications to the Department of Scientific & Industrial Research for R&D tax benefits and for establishing in-house R&D units — critical for MedTech startups claiming deductions under the Income Tax Act.
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MOFPI — Food Processing Industry
Regulatory support for manufacturers of combination healthcare-food products, medical nutrition, and enteral feeding devices under the Ministry of Food Processing Industries schemes.
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LMPC Certification
Legal Metrology Packaged Commodities certification for medical devices sold in consumer packaging — mandatory for all packaged goods under the Legal Metrology Act.
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EPR (e-Waste) Registration
Extended Producer Responsibility registration for active electromechanical medical devices under the E-Waste Management Rules 2022 — increasingly audited by CDSCO during inspections.
US Agent Representation
FDA-required US Agent services for Indian and international manufacturers without a US address — we receive FDA correspondence, relay notifications, and manage regulatory communications on your behalf.
European Authorised Representative (EC REP)
Mandatory EU MDR/IVDR EC REP services for non-EU manufacturers — we accept legal responsibility for regulatory compliance, maintain a copy of your technical documentation, and liaise with competent authorities.
