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DRUGCONSULTANTS 5aa63fc38783010e4427572b False 577 6
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FSSAI COMPLIANCE There are several guidelines and regulations under FSSAI which keep updating. It becomes difficult for manufacturers and importers in India to keep themselves updated on the same. We provide end to end support to the manufacturers and importers in India for the FSSAI compliance. Being an FSSAI license consultant, Our services include but are not limited to labeling analysis as per the FSSAI Packaging and Labelling regulations, 2011, ingredient and additive analysis, RDA analysis, formulation designing and review for product compliance as per acceptability in FSSAI.
CDSCO Guidelines India Drug license India CDSCO consultants in Delhi CDSCO medical device regulations India
CDSCO medical device regulations India Drug regulatory services in India Cosmetic Registration drug import Cosmetic Registration drug import india
We are one of the leading and reliable Regulatory Consultancy firms of INDIA present at your service for having well established Pharma Company in today's competitive corporate world. The Company Provides Regulatory Services for Dossiers / DMF / CTDs-ACTD / ANDA Drug regulatory services India Drug and cosmetic act Drug regulations India Drug Registration Delhi CDSCO Drug Registration consultant Drug/device/cosmetic import License services in India Food License in India CDSCO India Drug import in India
PRODUCT APPROVAL The products deviating from FSSAI regulations require product approval from FSSAI. The products falling outside the purview of food safety established for ingredients used need to approach the scientific panel of FSSAI. In order to help clients receive approval for their products, we at ACPL extend our support throughout the process of preparing and online filing of applications to FSSAI product approval department. Product formulation and label suggestions are also discussed with the client with special reference to FSSAI guidelines.
LEGALIZATION Any product that is exported to a particular country requires certain documents along with the shipment or beforehand as per the requirements and regulations of the importing country. Some of these documents like power of attorney, GMP certificate, COPP, COO any other commercial documents related to pharma is asked to be attested/ notarized/ legalized from the embassy (Ministry of External Affairs) of the importing country in Exporting country. This attestation/ notarized is mandatory to be done which ensures or verifies that the documents are original and from the country of origin/exporting country. We have a specialized team who focuses on all the legal documentations, notarizations, attestations, apostillation and legalizations. We assure complete satisfaction to our clients
Pharmacovigilance consultant in Delhi DCGI, CDSCO, Drug, Medical Device, cosmetic Registration/ license Consultant in India Drug regulatory services India Drug and cosmetic act Drug regulations India Drug Registration Delhi CDSCO Drug Registration consultant Drug/device/cosmetic import License services in India Food License in India CDSCO India Drug import in India Dossier Compilation for Emerging Markets/EU/US/Australia Types – eCTD, ACTD, NeeS, National Filing Preparation and filing of documents IND, NDA and ANDA Dossier conversions to CTD/ACTD for Drugs & to CSDT for Medical Devices CPP, DMF Reviews FDA/DCGI liaison meeting PIL User Testing API filing with EDQM for obtaining CEP Product label maintenance Import Licenses Registration PV Pharmacovigilance consultant Pharmacovigilance services in EU, USA, India, Russia CIS countries PVG modules, European Medical Agency Pharmacovigilance guidelines USFDA Adverse event reporting, ICSRs E2B reporting Clinical trial reports Medical device related reports Literature reports Aggregate & Periodic Report Writing PSURs, PBRERs, PADERs, DSURs, Bridge reports, Annual safety reports etc. Signal detection & Management Risk Management Plans (RMPs), REMS PSMF, QPPV (Qualified Person for Pharmacovigilance) PV audit and inspection Clinical Trial Monitoring Clinical Project management Clinical Trial Set-up Regulatory Affairs for Clinical Trials Patient Safety/Pharmacovigilance in Clinical Trials Clinical Data Management Clinical Biostatistics Services
Section 510 of the Federal Food, Drug, and Cosmetic Act (FD& C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S. agent and importers at the time of registration. DCGI, CDSCO, Drug, Medical Device, cosmetic Registration/ license Consultant in India Drug Regulatory Services India Drug and cosmetic Act Drug Regulations India Drug Registration Delhi
Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing by Central Drugs Standard Control Organization (CDSCO). The regulations under Drugs and Cosmetics Rules describe the information required for approval of an application to import or manufacture of new drug for marketing. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Till date, applicants have used many different approaches in organizing the information and the differences in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data or analyses. Such omissions can result in unnecessary delays in approvals. Very often, a client simply doesn’t have the time to complete the work. That’s where ACPL Consulting services help. Our Team will work with you to ensure that your requirements are met and that your completed work is delivered on time and, crucially, within budget. We have outlined the major areas of Regulatory operations and expertise under each of the service areas.
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