Post-Approval Maintenance Support

Post-Approval Life-Cycle Management of Marketing Applications

For over 30 years, Beckloff Associates, Inc. has been providing global regulatory support and guidance to the pharmaceutical industry. Our broad range of experience and resources help our clients achieve the scientific, regulatory and product performance goals that best suit their clinical and commercial needs.

To add to our already impressive list of offerings, Beckloff Associates is expanding our services through a partner-based, milestone-driven business model specifically aimed at providing support for post-approval life-cycle management of marketing applications. Our partnering model is highly flexible, allowing it to be easily customized to individual customer requirements.

How does it work?

This model involves designating one or more of our highly experienced technical consultants as a dedicated resource to your organization. Our consultants are experienced and can quickly adapt to your specific company requirements, and essentially becomes an extension of your existing staff. Our unique understanding of the regulatory process allows our consultant(s) to:
  • Work independently, or under the direction of a member of your management team,
  • Help to establish your regulatory strategy for maintaining globally consistent submissions,
  • Interact with your manufacturing group(s) to evaluate deviations and change controls for global regulatory impact, and
  • Provide submission ready documents prepared according to your specific internal requirements, or prepared using one of our established templates.

The ability to provide experienced high level strategic consulting as well as technical writing sets our team apart from other consulting firms.

Partnering model

  • On-site Training or Support Specific to your organization (as needed)
  • Secure Communication (on-site meeting or teleconferencing, FTP, Share-Point)
  • Regulatory Strategy Recommendations and Implementation
  • Project Management
  • Agency Interactions
  • Application Preparation (Supplemental NDA?s, Amendments, Variations, Annual Reports)

Post-Approval Services

  • Strategic Product Development
  • Compliance Audits
  • Comprehensive Due Diligence
  • Vendor Management
  • Manufacturing Change Assessments (Change Control, Deviations, Global Regulatory Impact)
  • Customized Global Regulatory Strategy
  • Regulatory Filing Category Recommendations
  • Regulatory Affairs Activity Management
  • Application Life-cycle Management
  • Market Expansion
  • Application Preparation and Submission (Agency Responses, Amendments, Supplements, Periodic Safety Reports and Annual Reports)
    • CTD Format and eCTD (conversions)
    • Changes to API supplier
    • Changes to formulated product
    • Packaging/Labeling changes
    • Drug Listing
    • Marketing Materials (DDMAC)
    • Scale-up prior to launch
    • Product Transfer (to new Company)
    • DMF/ASMF
  • IND and NDA Maintenance
    • Annual Reports
    • Safety Reports ? IND and NDA
    • Periodic Safety Update Reports
    • REMs / Registries
    • Physician Labeling Rule development
    • Strategic Prescribing Information compliance - new FDA guidance?s, Dosage and Administration, Contraindications and Warnings, Adverse Reactions, Clinical Studies.
    • Labeling Updates ? Pediatric, Geriatrics, Renal, Hepatic and Drug Interactions
    • Global core labeling
    • SPC development and updates
    • Target Product Profiles
    • Doc portal/gateway submissions
  • Phase IIIb and IV Studies
    • Protocol Development and Review
    • Investigator Initiated Trials development and review
  • Marketing Materials (DDMAC)
    • Pre and Post launch timing and strategy
    • Advertising and Promotional Review, process development and compliance.
    • Standard Operating Procedures (SOPs)
    • Form FDA 2253 administration and auditing
    • DDMAC interaction and negotiations, Notice of Violations, Warning letter resolution
    • Patient Prescribing Information development and submission
  • Medical Affairs
    • Independent Research
    • Product specific research
    • Publications
    • Scientific slide presentation - consultant and key opinion leader training
    • Sales training materials
    • Drug Monographs
    • Drug Information Standards