MEDATEQ LABS can assist Pharmaceuticals / Food / Cosmetic / Medical device companies to register and carry out licensing work with DCGI – Drug General Controller of India. DCGI is responsible for Regulation of Drug & Cosmetics in India.
MEDATEQ LABS offers end-to-end expertise to ensure your submissions are flawless and approved without administrative delays.
Complete onboarding for firms, technical personnel, and manufacturing units on the ONDLS Official Platform.
Precise handling of diverse electronic applications, including manufacturing licenses, retail/wholesale sale licenses, and blood bank operations.
Enables applicant firms to track application review statuses, query responses, and final license approvals live.
MEDATEQ LABS provides the following service with regards to DCGI
Import Registration of Drugs / API in India / Form 43 registration with DCGI India.
Site Registration with DCGI India
Cosmetic Registration for import in India. – Form 44
New product License for manufacturing in India with ONDLS PORTAL
FSSAI registration i.e. Food & Ingredients registration in India
BE Studies NOC
WC registration In India
Medical Device Registration with SUGAM PORTAL (CDSCO)
Dossier Preparation (For all kind of submissions)
Prepare dossiers for various applications like Clinical trial approval (Form-45),
Manufacturing/import permission (Form-45 ),
Test license (Form-11),
Drug Registration certificate (Form- 41),
Import license (Form-10),
Neutral code, NOCs of different purpose,
Drug Sales license (Form – 20 B & 21 B),
CLAA approval, Manufacturing license (Form – 28, 28 A ),
Cosmetics Registration certificate (Form- 43) etc.
Food Registration certificate (Form- A & B).
MEDATEQ LABS auditing facility design, equipment, and documentation against the Revised Schedule M standards.
Drafting and updating Site Master Files (SMF), Standard Operating Procedures (SOPs), Validation Master Plans (VMP), and Batch Manufacturing Records (BMR).
Implementing updated risk management protocols, change control systems, and data integrity controls.
Conducting required stability testing, validation studies, and raw material/finished product analysis in compliance with updated lab controls.
Preparing and technical review of the audit-ready dossiers required for submission to the State FDA and CDSCO.
