Welcome to Rexllance

API manufacturers and importers in India must obtain a licence under Schedule M of the Drugs & Cosmetics Act, 1940, with applications filed via Form 27/27A (manufacturing) or Form 41/45 (import) through CDSCO's SUGAM portal. New APIs require DCGI approval under the New Drugs & Clinical Trials Rules, 2019, with mandatory NIB/IPC quality testing for every imported batch. At Rexllance, we manage your complete API regulatory lifecycle — from initial licensing and new registrations to post-approval variations and ongoing compliance.

We support sponsors in preparing and submitting IND applications to CDSCO via the SUGAM portal, including Phase I–III clinical trial applications, protocol submissions, SEC presentations, CT NOC follow-ups, and regulatory query responses to ensure timely approvals.

We guide innovator and generic companies through the entire NDA process under the New Drugs and Clinical Trials Rules 2019 — including dossier preparation in CTD format, Form 44 submissions, CDSCO query management, and approval tracking for new chemical entities and biosimilars.

FDC approvals require robust justification of therapeutic rationale and safety data. We prepare FDC dossiers compliant with CDSCO guidelines, manage SEC review presentations, respond to expert committee queries, and coordinate with licensing authorities for state and central approvals.

Biological products including vaccines, recombinant proteins, and monoclonal antibodies follow a specialised CDSCO pathway involving RCGM clearance, GEAC approvals where applicable, and NIB lot release testing. We provide end-to-end dossier and regulatory support for this complex category.

Veterinary drugs require separate licensing under the Drugs & Cosmetics Act through CDSCO's veterinary division. We handle product registration, manufacturing licence applications, import approvals, and coordination with state licensing authorities for veterinary pharmaceutical products.

We provide regulatory support for BE studies and NDCTs — including CT NOC applications, ethics committee registrations, SUGAM submissions, SEC meeting preparation, and regulatory query responses — ensuring your trial stays on track and compliant throughout.

Any change to an approved product — formulation, manufacturing site, packaging, or labelling — requires a PAC submission to CDSCO. We classify, prepare, and submit PAC dossiers as per CDSCO guidance, managing the full review cycle including queries and approvals.

WC certificates are mandatory for exporting pharmaceutical products to certain regulated markets. We prepare and submit WC applications to CDSCO, coordinate with the relevant divisions, and ensure timely issuance to support your export timelines without delays.

We facilitate sample submissions to national testing laboratories — NIB (National Institute of Biologicals), IPC (Indian Pharmacopoeia Commission), and CDTL (Central Drugs Testing Laboratory) — for quality, potency, and lot release testing as required by CDSCO regulatory guidelines.

Subject Expert Committee (SEC) meetings are critical decision points in CDSCO's review process. We prepare compelling, data-driven presentations, anticipate committee queries, coach your team on response strategies, and ensure your product's case is presented with clarity and scientific rigour.

Abbreviated New Drug Applications enable generic products to gain CDSCO approval based on bioequivalence with a reference listed drug. We prepare CTD-compliant ANDA dossiers, manage CDSCO interactions, and handle query responses for both API and finished dosage form submissions.

Cosmetics imported into India require registration under the Cosmetics Rules 2020 via SUGAM portal. We manage the complete import registration process — from product classification and dossier preparation to CDSCO submission and licence issuance — for all cosmetic categories.

Medical devices and in-vitro diagnostics are regulated under the MDR 2017. We support import and manufacturing registrations (Class A–D), CDSCO licence applications, performance evaluation report submissions, and post-market compliance for both domestic and international device manufacturers.

Blood banks require licensing under Schedule F (Part XII-B) of the Drugs & Cosmetics Act. We assist with licence applications, facility compliance reviews, CDSCO and state licensing authority coordination, and renewal management to ensure uninterrupted operations.

PSURs are mandatory pharmacovigilance submissions summarising a product's benefit-risk profile over a defined period. We prepare PSURs in compliance with CDSCO and ICH E2C guidelines, ensuring accurate safety data integration, timely submission, and complete regulatory documentation.

Serious Adverse Events (SAEs) occurring during clinical trials must be reported to CDSCO within defined timelines. We manage expedited SAE reporting, prepare MedWatch and CIOMS forms, coordinate investigator communications, and maintain compliance with CDSCO and ICH E6 reporting requirements.

Ethics Committees conducting review of clinical trials must be registered with CDSCO under the New Drugs and Clinical Trials Rules 2019. We assist institutions with registration applications, documentation, standard operating procedure development, and renewal submissions.

SUGAM is CDSCO's online portal for drug and device regulatory submissions. We manage end-to-end SUGAM registration — from portal enrolment and user account setup to application filing, document uploads, status tracking, and resolving technical or regulatory queries raised by the system.

We continuously monitor CDSCO, FSSAI, NPPA, WHO, ICH, and other global regulatory bodies — delivering timely alerts, circular summaries, and strategic impact analyses to help you stay ahead of regulatory changes and make proactive, informed business decisions.

Certain products and activities require approvals directly from the Ministry of Health & Family Welfare or the Department of Biotechnology. We coordinate and manage these multi-departmental licensing processes, including for biologics, clinical research organisations, and import/export authorisations.

Ayurvedic, Unani, Siddha, and Homeopathic products are regulated under the Drugs & Cosmetics Act with separate licensing requirements. Nutraceuticals and health supplements fall under FSSAI. We handle licensing, product approvals, labelling compliance, and import registrations across all these categories.

Food businesses, nutraceuticals, and health supplement manufacturers require FSSAI central or state licences. We manage licence applications, product approvals, label reviews for compliance with FSS Regulations, and liaison with FSSAI authorities for queries and renewals.

The National Pharmaceutical Pricing Authority regulates drug prices under DPCO 2013. We assist manufacturers and importers with price filing, Form I & V submissions, compliance monitoring, revision notifications, and responding to NPPA queries to ensure full pricing regulation adherence.