Navigate Global & Indian Regulatory Frameworks with Confidence

Pharmaceutical compliance isn’t optional — it’s foundational. We help companies achieve, maintain, and audit compliance with major regulatory authorities across the globe and in India, so you can launch, scale, or operate without costly delays or deviations.

Whether you’re planning a new facility, product launch, export strategy, or certification upgrade, we provide strategic guidance, operational readiness support, and regulatory submission planning.

Core Compliance Services

Compliance Gap Assessment: We objectively evaluate your QMS, documentation, infrastructure, and processes against applicable standards.

Licensing & Form Filing Support: Tailored support with central & state level filings, including recommendations for:

  • USFDA facility registration

  • MHRA GMP license

  • CDSCO Forms (1, 11, 20B, 21B, 24, 27D, 28, 44 etc.)

  • Export licenses & import permits

We explain what to file and when, so you avoid multiple revisions.

Regulatory Compliance Assessment Request

Submit basic details to receive a preliminary compliance roadmap.

Process

How We Work

We assess your facility, products, and target markets to identify applicable regulatory requirements.
A focused gap analysis is conducted against standards such as USFDA, MHRA, WHO-GMP, PIC/S, or Revised Schedule M.

Discovery & Intake

 Understand your product, market, facility status..

Compliance Roadmap

Customized plan with milestones, documentation checklists and timelines.

Execution Support

Template SOPs, manufacturing dossiers, audit prep packages.

Inspection Readiness

Pre-audit reviews, mock inspections, corrective plans.

Frequently Asked Questions

Depends on markets you want to sell in — we map this early and align your compliance path accordingly.

Yes — we provide templates aligned with GMP expectations for your chosen framework.

It depends on your current status — but most facilities achieve readiness in 6–12 weeks with focused effort.

Yes — we guide you on form types and submission strategies based on your plan.