Regulatory  Consulting

Calibration and Validation

Valical regulatory consultants provide a wealth of knowledge on the most current regulations, directives, laws, policies and guidelines issued by regulated authorities around the world.

 

We sift through the often arcane language of regulation to understand details, interpret guidelines and recommend the right solution tailored for your organization. We provide regulatory advice, develop strategies for challenging situations and advocate on your behalf with regulatory agencies.

We provide consolation on:

  • Strategy
  • Intelligence
  • Compliance

Regulatory Strategy Consulting

  • Regulatory strategic planning from design to market for drugs, devices & drug device combination products.
  • Specialized strategic planning for fast track and orphan products
  • Advice on DPI /MDI, Sterile, Injectable, Biosimilars and advance therapies
  • Product classification review
  • FDA representation at key milestone meetings.
  • Labelling and advertising review
  • Development of risk management plan (RMP) and risk evaluation and mitigation strategies (REM)

Regulatory Intelligence Consulting

  • Leverage current regulatory approvals to penetrate new market quickly and cost effectively.
  • Access, summarize & assess global regulatory intelligence to ensure submission compliance with regional and local requirements.
  • Ongoing surveillance of regional and local authorities to ensure that product development & registration planning strategies are sound and rigorous.
  • Survey competitive landscape & utilize competitive gap analysis technique to provide regulatory intelligence supporting product benchmarking.

Regulatory Compliance consulting

With expertise in product development QA. QC, current technologies and global regulation, our consultants assess client compliance from all perspectives of processes, tools and people.

 

Our compliance services include:

  • Assessment of current compliance level (Gap assessment)
  • Harmonization and development of standard operating procedures (SOP)
  • Audits of independent quality systems (ISO, GCP, GLP, GMP, GCDMP, GPVP) facilities, vendors, processes, projects, programs and studies.
  • Management of corrective and preventive action (CAPA) program
  • ANDA and DMF review
  • Remediation to warning letters & 483 observations
  • Response writing to FDA observations
  • USP compendial ( sterile, non-sterile, OSDs, capsules, gels & ointment, liquid orals, inhalers, transdermal etc.)
  • Development of tools for monitoring and tracking compliance