Author Archives: docentpharma

ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD)
U.S.A/Canada/Europe U.S.FDA’s ESG Submission

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

Assist in USFDA eCTD Submission
Assist in Health Canada eCTD Submssion
Assist in European eCTD Submission

Docent Pharma’s Regulatory Consultant/Specialist assists you for eCTD creation and submission.

DRUG LABELING REVIEW
Human & Animal Drug Rx & OTC Drugs U.S.FDA/Health Canada/EU/Emerging Markets

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
BA/BE/PK studies/Toxstudy Protocol & Reports Review

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-eCTD
Doc-e-Touch Tool Box Automated functions Inherit zoom/PDF version & Fast Web Access

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
Word Format & Well Formatted Production/QA/QC/Auditing Validation/Submission

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)
  • Microbiology
  • Method Validation
  • Auditing
  • Regulatory Submission
  • ECTD/CTD/ACTD Dossier Template

Advantages of Docent Pharma’s SOPs & Templates :

  • Word Format
  • Well-Formatted
  • Easy to Edit
  • Diagrams & Pictures to Simplify & Improve their Use

U.S.AGENT

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.