End-to-End Development Support for USFDA Generic Formulation and MHRA Submission

Pertecnica Engineering offers a specialized training program designed to provide comprehensive support for the development and submission of generic formulations for the USFDA and MHRA. This program is tailored for professionals involved in pharmaceutical development, regulatory affairs, and quality assurance, focusing on the intricacies of generic drug formulation and the regulatory submission processes for the USFDA and MHRA.

Program Overview

Our End-to-End Development Support Training Program covers all stages of generic drug development, from formulation and development through to regulatory submission and approval. Participants will gain practical insights and strategies to navigate the complexities of both USFDA and MHRA regulatory requirements.

Comprehensive Syllabus

  1. Introduction to Generic Drug Development
    • Overview of the generic drug approval process
    • Differences between branded and generic drug development
    • Key considerations for successful generic formulation
  2. Formulation Development
    • Principles of generic formulation design
    • Analytical methods for formulation development
    • Bioequivalence studies and requirements
  3. Regulatory Requirements for USFDA
    • Understanding the USFDA regulatory framework
    • Preparation and submission of Abbreviated New Drug Applications (ANDAs)
    • Compliance with USFDA guidelines and standards
    • Handling USFDA inspections and audits
  4. Regulatory Requirements for MHRA
    • Overview of the MHRA regulatory process
    • Preparation and submission of Marketing Authorization Applications (MAAs)
    • Compliance with MHRA guidelines and standards
    • Interaction with MHRA and handling of regulatory queries
  5. Documentation and Quality Assurance
    • Essential documents for USFDA and MHRA submissions
    • Best practices in documentation and record-keeping
    • Quality management systems and ensuring regulatory compliance
  6. Pre-Submission Activities
    • Preparing for pre-submission meetings with regulatory agencies
    • Addressing common issues and queries from USFDA and MHRA
    • Strategic planning for successful submissions
  7. Post-Submission Activities
    • Responding to regulatory feedback and queries
    • Managing post-approval changes and submissions
    • Handling market entry and commercialization challenges
  8. Case Studies and Real-World Scenarios
    • Analysis of successful generic drug submissions
    • Lessons learned from regulatory challenges and resolutions

Training Methodology

  • Expert Lectures: Detailed explanations of regulatory requirements and formulation strategies.
  • Interactive Workshops: Hands-on sessions focusing on practical aspects of formulation and submission.
  • Case Studies: Real-world examples and analysis of successful regulatory submissions.
  • Q&A Sessions: Opportunities to discuss specific challenges and queries with industry experts.

Program Duration and Schedule

The training program is available in both full-time and part-time formats, providing flexibility for working professionals. The course typically spans [X] weeks, with sessions held [X] times per week.

Who Should Attend?

  • Pharmaceutical development teams
  • Regulatory affairs professionals
  • Quality assurance and compliance officers
  • Formulation scientists and engineers

Certification

Upon successful completion of the program, participants will receive a certificate from Pertecnica Engineering, demonstrating their expertise in USFDA and MHRA regulatory processes for generic formulations.

Enroll Now

Advance your knowledge and skills in generic drug development and regulatory submissions by enrolling in our End-to-End Development Support Training Program. For more information on course dates, fees, and registration, please contact us