Monthly Archives: August 2013

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U.S.FDA-DRUG ESTABLISHMENT REGISTRATION & LISTING
Human & Animal Drug Rx & OTC Drugs

U.S.FDA-DRUG ESTABLISHMENT REGISTRATION & LISTING

Docent Pharma has extensive experience of converting and creating U.S.FDA compliant & validated SPL files (XML). SPL Conversion Services include creation of SPL submission package to U.S.FDA for the following types of submission and secure transmission to U.S.FDA, will meet company needs for eDRLS (Electronic Drug Registration and Listing Systems).

  • NDC/NHRIC Labeler Code Request
  • Drug Establishment Registration
  • Drug Listing

Benefit of Docent Pharma’s SPL Conversion Services;

  • Fast, Accurate, and Cost Effective Service
  • Reduces Expenses Related to In-House SPL Software & It’s Maintenance and Staff
  • Performing In-Depth SPL Validation for U.S.FDA Compliant SPL Submission
  • Checking Format Data Values (D-U-N-S Number, FEI Number, Labeler Code, etc)
  • Lifecycle Management for SPL Submission
  • Data Protection through Our Secure Environment

Docent Pharma Can Assist :

  • Human & Animal Drug
  • Rx & OTC Drugs
  • Bulk Drug/Active Drug Substance Manufacturer
  • Medical Gas Transfiller
  • Domestic/Foreign Manufacturers
  • Own/Private Label Distributor
  • Contract Testing Lab
  • Repacker/Relabeler

Additional Assistance :

  • Procurement of D&B D-U-N-S® Number
  • Label Review & Compliance for U.S.FDA Submission

U.S.FDA-MEDICAL DEVICE REGISTRATION & LISTING
Manufacturer/Sterilizer Exporter/Importer

U.S.FDA-MEDICAL DEVICE ESTABLISHMENT REGISTRATION & LISTING

The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver.

Owners or operators of establishments or facilities (Domestic/Foreign) that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register/listing with the U.S.FDA.
All device establishments must complete their annual registration for each Fiscal Year between October 1 and December 31.

Note:

All establishments must pay a required U.S. FDA’s Medical Device User Fees.

Docent Pharma Can Assist :

  • Manufacturer
  • Contract Manufacturer
  • Contract Sterilizer
  • Foreign Exporter
  • Initial Importer
  • Repackager
  • Relabeler
  • Remanufacturer
  • Reprocessor

U.S.FDA-COSMETICS REGISTRATION & REPORTING
VCRP/CPIS California Safe Cosmetics Program

U.S.FDA-COSMETICS REGISTRATION & REPORTING

Docent Pharma provides following assistance in Registration and Ingredient Statement filing for U.S/Non-U.S Cosmetic companies

  • U.S. FDA Voluntary Cosmetic Registration Program (VCRP)
  • U.S. FDA Cosmetic Product Ingredient Statement (CPIS) Filings.
  • California Safe Cosmetics Program (CSCP) Registration Requirements.

GDUFA & SELF-IDENTIFICATION
API/Drug Product Facilities Contract Re-packager/Testing Lab BA/BE Sites

GENERIC DRUG USER FEE ACT (GDUFA) & SELF-IDENTIFICATION SPL SUBMISSION

Beginning in fiscal year 2013, the U.S.FDA will assess and collect facilities fees in accordance with generic drug user fee act (GDUFA) program. These include facilities manufacturing, or intending to manufacture, active pharmaceutical ingredient (API) of human generic drugs and/or finished dosage form (FDF) human generic drugs. Other sites and organizations must self- identify, but will not be required to pay the annual facility user fee.

Following types of generic industry facilities, sites, and organizations are required to self- identify with U.S.FDA:

  • Human generic drug APIs or Drug Product or both.
  • Sites and organizations that package the human generic drug product into the primary container/closure system and label the primary container/closure system.
  • Contract re-packager of human generic drug product.
  • Bioequivalence (BE)/bioavailability (BA) sites.
  • API/Drug product contract testing laboratory.

Docent Pharma offers following services to help human generic drug facilities, sites, and organizations prepare to meet the GDUFA self-identification requirement.

  • Guidance & Procurement for Data Universal Numbering System (DUNS) numbers.
  • Creating the Self-Identification Submission in SPL Format
  • Electronic Submissions Gateway (ESG) Submission.
  • Consultancy on Generic Drug User Fee Act (GDUFA)

U.S.FDA-AFFORDABLE CARE ACT (ACA 6004) SUBMISSION
Drug Sample Distribution Submission Manufacturers/Distributors

U.S.FDA-AFFORDABLE CARE ACT (ACA 6004)/
DRUG SAMPLE DISTRIBUTION SUBMISSION SERVICES

Affordable Care Act (ACA 6004) states that manufacturers and authorized distributors must submit the information concerning drug sample distribution to U.S.FDA. U.S.FDA has indicated that it will require industry to submit this information electronically via the Electronic Submissions Gateway (ESG) in an XML format.

As your trusted electronic submission service provider, Docent Pharma is developing a solution to meet your needs for ACA 6004 submissions.

U.S.FDA DETENTION
For Drugs Non-compliance with U.S.FDA Requirement Manufacturer/Exporter/Importer

U.S.FDA DETENTION – DRUG

Most of the drugs detained by U.S.FDA are due to non-compliance with U.S.FDA requirements.

The most common reasons U.S.FDA detain Drugs:

  • Drug establishment is not registered with U.S.FDA
  • Drug product is not listed with U.S.FDA
  • Active Pharmaceutical Ingredients (API) is not listed with U.S.FDA
  • OTC Drug Product doesn’t follow OTC Monograph
  • Drugs / API’s doesn’t have proper labeling

Docent Pharma’s Regulatory Consultant/Specialist assists exporters and importers to release the detained drugs by brought the drugs in to compliance with the U.S.FDA regulations.

U.S. FDA PLAIR SUBMISSION

A Pre-Launch Activities Importation Request, also known as a PLAIR, is permit importation of unapproved finished dosage form drug products based upon anticipated approval of a new drug application (NDA), an abbreviated new drug application (ANDA), or a Biologics License Application (BLA) regulated by U.S.FDA’s Center for Drug Evaluation and Research (CDER) to prepare the drug products for market launch.
Docent Pharma’s Regulatory Consultant/Specialist assists you to applying and obtaining the PLAIR for your drug product prior to U.S.FDA approval.

DOSSIER/DMF COMPILATION
U.S.A/Canada/Europe Emerging Markets Clinical/Non-Clinical Overview

DOSSIER/DMF COMPILATION SERVICES

Docent Pharma services have handled many regulatory submissions, in different countries, on behalf of client companies.

Docent Pharma Regulatory Consultant assists Life Science Clients with the following services:

  • Compilation/Preparation of Dossier in CTD [Common Technical Document] Format [Module 1 – Regional, Module 2 to Module 5]
  • Compilation/Preparation of DMF [Drug Master File]
  • Compilation/Preparation of Dossier in ACTD [Asean Common Technical Dossier] Format
  • Amendment, Supplement, Annual Report, Annual Updates & Variation Application Compilation for Regulated & Emerging Market
  • Dossier/DMF Review & Gap Analysis
  • Clinical/Non-Clinical Overview
  • Responses for MOH/Authority Queries

Docent Pharma Can Assist :

Regulated Market Submission

  • U.S.A
  • Canada
  • Europe

Emerging Market Submission

  • Asian Countries
  • Southeast Asia Countries
  • CIS Countries
  • African Countries
  • Latin America
  • GCC Countries