Professional Experience of Service Provider More than 5 Years Approval From Drugs Controller General India, Team More than 10 Professionals, Domain Regulatory Affairs - Expert Consultants

Description drugs controller general originating in India central drugs standard control organization under the the regulation of manufacture, Sale and distribution of, Drug and cosmetics act drugs is primarily the concern pertaining to the jurisdiction authorities while the central authorities are responsible for approval of clinical trials, New drugs in laying down, The country the standards oversight of, For drugs the caliber of imported drugs, Coordination of the activities of state drug control organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the legislation governing drugs and cosmetics. Drug controller general of india is responsible for approval of licenses of specified categories of drugs such as blood and i. V, Blood products. Fluids, Vaccine and sera. Central drugs standard control organization head quarter is positioned at new delhi, Kotla road, Fda bhawan 110002 and functions under the directorate general of health services new drugs approvals manufacturing approvals of fdcs and single molecule new drugs on stability study, Bio, Equivalence study, Clinical trial study or toxicity study. Manufacturing approval of bulk drugs in india. Strategy development for approval of 1st time fdc. Preparation of rationale and justification for fixed dose combination fdc expediting expert letters from dcgi to experts. Assistance in preparation of form 44 read with appendix 1 to schedule y for clinical trial approvals, Global/ india specific. Import registrations of drugs biologicals medical devices diagnostics blood products registration/re, Registration of foreign manufacturing premisesimport registration of individual formulations, Bulk drugs, Medical devices and cosmeticsproviding import license in form 10test license to attain the goal of test or, Of examination analysis in form 11. Urgent import of life saving drugs or import of personal use drugsgetting export permissions for the export of bulk drugs and formulations. Certificate of pharmaceutical product copp, Who gmp from zonal offices. Assistance in rule 37 permission to re, Pack . Organizing testing of samples at various central drug laboratories. Organizing testing of samples at national institute of biologicals noida. Indian agent representationto achieve legally register, Import and market, Sell your medical products in india you must be compliant to indian regulations and legislation. When a company does not have a registered and physical office with statutory personnel and required licenses a legal, In india india authorized representative / agent with the above needs is meant to be formally appointed. This authorized representative will also be held responsible for pre, Certification and post, Market surveillance inquiries. Nkc will represent the client s organization as the official indian authorized representative / agent in agreement with india applicable regulatory legislation the drugs and cosmetics act and rules. Only one indian authorized representative office is crucial for the whole country. Nkc will represent the client legally in india without any commercial conflict of interest activities like product sales, Product marketing, Product distribution etc. We will pursue the application assessment and notify when the registration is accepted.