Docent Pharma is a regulatory affairs comprehensive consulting service.
Docent Pharma acts as knowledgeable guide on Regulatory Affairs to Pharmaceutical companies wanting to introduce products into global markets.
Docent Pharma is works in close collaboration with pharmaceutical clients to provide innovative, reliable, customized & cost effective solution.
The team at Docent Pharma consists of well qualified and dedicated staff with rich experience of dossier compilation, electronic submission, labeling and compliance across global drug authorities.
“We ensure exceptional and reliable quality in all aspects of our work”
“Provide innovative, reliable, customized & cost effective solution”
“Experienced team will provide more efficient compilation and compliance execution”
“Develops long-term relationship with clients, based on the highest levels of integrity, professionalism and trust”
“Believe that a client’s privacy is of paramount importance”
Docent Pharma is committed to not only meeting your needs, but exceeding your expectations, as evidenced through our core values:
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
Additional Assistance :
- Procurement of D&B D-U-N-S® Number
- Label Review & Compliance for U.S.FDA Submission
U.S. FDA FOOD, BEVERAGE AND DIETARY SUPPLEMENT REGISTRATION
Docent Pharma’s U.S.FDA Food, Beverage & dietary supplement registration services include:
- U.S. FDA Food Facility Registration
- U.S.FDA Prior Notice of Imported Food
- U.S. FDA Food Canning Establishment (FCE) Registration & Process Filings (SID)
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.
All establishments must pay a required U.S. FDA’s Medical Device User Fees.
Docent Pharma Can Assist :
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Initial Importer
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.
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)/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 – 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 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
Emerging Market Submission
- Asian Countries
- Southeast Asia Countries
- CIS Countries
- African Countries
- Latin America
- GCC Countries
ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) SERVICES
eCTD submissions are increasingly recommended by International drug regulatory agencies such as U.S.FDA, EMA, Health Canada.
Docent Pharma offers the following eCTD services to Life Science Clients:
- Document Development for eCTD Submissions readiness
- Submissions Compilation & Assembly for Dossier(Module 1 – Regional, CTD Module 2 to Module 5)
- Submissions Compilation & Assembly for DMF
- Consultancy for Transition from Paper Based System to eCTD Format
- U.S.FDA’s Electronic Submissions Gateway (ESG) Submission
Docent Pharma’s Regulatory Consultant/Specialist assists you for eCTD creation and submission.
DRUG LABELING REVIEW SERVICES
Docent Pharma’s Drug Labeling Review Service assists Life Science clients/ companies determine their drug’s compliance with applicable labeling requirements & legislation.
Docent Pharma’s Drug Labeling Review Services include, but not limited to:
- Package Leaflet/Insert Review
- Product Monograph Review
- Container Label/Mock-Up Review
- OTC Drug Facts Review
Docent Pharma’s Drug Labeling Review Service provides:
- A detailed label review report with comments/recommendations
- No extra cost for review of corrected/revised labels
Docent Pharma Provide Assistance In :
- Human/Animal Drug
- Over The Counter (OTC) Drug
- Prescription (Rx) Drug
- U.S.FDA Submission
- Health Canada Submission
- EU Submission
- Emerging Market Submission
CLINICAL & NON-CLINICAL STUDIES
Docent Pharma have active association with approved study centers with state of art facilities to perform bioavailability, bioequivalence, pharmacokinetics and animal toxicological studies.
Docent Pharma Can Assist in Clinical/ Non-clinical studies management;
- Source a CRO
- Toxicity studies
- Advice and review of BA/BE/PK studies/Toxstudy designs.
- Review & helping in preparation of Protocol & Reports.
- Monitor studies to ensure Good Clinical Practice (GCP)/ Good Laboratory Practice (GLP) compliance.
Docent Pharma’s Advantage :
- Effective Coordination
- Low cost due to our long-term alliance with CROs
- Providing complete protocol, report and chromatograms
- Handling all pre & post-registration queries
PDF TOOL FOR eCTD SUBMISSION
eCTD submission now a reality for the life sciences industries, it is essential that organizations prepare PDF documents in accordance with regulatory requirements before beginning compilation of the eCTD submission. The generation of eCTD ready PDF documents often turns out to be more time consuming than the eCTD publishing itself.
Doc-e-Touch helps to address PDF document readiness challenges in a simple and streamlined manner. Automated features in Doc-e-Touch help ensure that PDF documents are agency compliant.
Why Use Doc-e-Touch?
Unlike any other offering or approach, Doc-e-Touch is not just a “tool-box” but a solution that automates;
- Inherit zoom setting for bookmarking & hypertext linking
- Setting for the PDF version 1.4,
- Setting for ‘PDF Fast Web Access’ active
Doc-e-Touch User Benefits
- Automated functions for consistency and error reduction
- Process and manage source documents in a batch process as opposed to one document at a time.
- Fixing PDF setting is as easy as Find & Replace
- Intuitive and easy to use for immediate return on investment
SOPs & TAMPLATEs
Docent Pharma’s Regulatory Consultants are specialises in writing Standard Operating Procedures (SOPs)/Forms/Templates, to ensure that activities and tasks in pharmaceutical manufacturing & research environments are performed in a compliant manner.
Docent Pharma’s step by step pre-written standard operating procedures, forms and templates are created in the following area for small and medium size pharmaceutical companies;
- Production Operations
- Quality Assurance (QA)
- Quality Control (QC)
- Method Validation
- Regulatory Submission
- ECTD/CTD/ACTD Dossier Template
Advantages of Docent Pharma’s SOPs & Templates :
- Word Format
- Easy to Edit
- Diagrams & Pictures to Simplify & Improve their Use
U.S. AGENT REQUIREMENTS
Are you a non-US manufacturer of Pharmaceutical Products or Drugs & Medical Devices, or Foods & Food Products?
Docent Pharma has experience in providing U.S agent services and provides U.S Agent services at very competitive charges.
For more information on U.S agent services contact us.