End-to-End Pharmaceutical Services

Our Services

Integrated CMC, R&D, and Regulatory expertise.

From lab bench to market — science-first, globally aligned, submission-ready.

CMC Services

From lab bench to market, we cover the full Chemistry, Manufacturing & Controls spectrum.

CMC Development & Strategy

  • Regulatory CMC gap analysis
  • CTD Module 2 & 3 authoring
  • API/DP comparability assessments

Strategic Foundation

Drug Substance (API)

  • DMF/ASMF/CEP preparation
  • Impurity profiling & reference standards
  • API stability programs

API Excellence

Lifecycle CMC Management

  • Post-approval variations & supplements
  • Comparability protocols
  • Renewals & ongoing compliance

Long-Term Success

R&D Services

Innovative formulations designed for global compliance and commercial success.

Drug Product (Formulation)

  • Pre-formulation & excipient compatibility
  • Formulation & process development (injectables, orals, ophthalmics)
  • Container-closure systems & E&L studies

Formulation Science

Analytical & Quality

  • Method development & validation
  • Dissolution/discriminatory methods
  • Forced degradation & stability-indicating assays
  • ICH stability studies & reporting

Quality Assurance

Manufacturing & Tech Transfer

  • Scale-up & exhibit batch oversight
  • Process validation (protocols & reports)
  • Tech transfer packages for CDMOs/CMOs

Commercial Readiness

Dosage Form Expertise

Injectables

Depot, RTU, nanosuspensions, emulsions

Ophthalmics

Solutions, suspensions

Oral Solids

IR, ER, MUPS, multilayer, pellets

Oral Liquids

Solutions, suspensions, pediatrics

Core Services

  • Pre-formulation & formulation development
  • ICH stability studies
  • Tech transfer documentation
  • Analytical method development & validation
  • Exhibit batch & scale-up support

Flexible Engagement Models

Fee-for-Service

  • Milestone-driven, transparent costs

Co-Development

  • Shared risk, shared IP/commercial rights
  • Differentiated formulations
  • 505(b)(2) strategies
  • Lifecycle extensions & repurposed assets

Regulatory Affairs Service

Global strategy. Local compliance. Submission-ready execution.

EMA (EU)

  • Centralized, DCP, MRP, NP submissions
  • Scientific advice briefing books
  • eCTD dossier preparation (Modules 1–5)
  • Lifecycle management (variations, renewals, notifications)

UK (MHRA)

  • National procedure & reliance routes
  • eCTD dossier compilation & submission
  • Pre-submission & accelerated review support
  • Lifecycle activities (variations, PSURs, renewals)

US (FDA)

  • Pathway assessment: 505(b)(1), 505(b)(2), ANDA
  • Pre-IND & pre-NDA meeting support
  • IND, DMF, ANDA, NDA dossier preparation
  • ESG/eCTD publishing & SPL creation
  • Responses to IR, DRL, CRL
  • Labeling & SPL compliance

Commercial Readiness

Special Capabilities

  • EMA centralized vs. DCP/MRP guidance
  • UK reliance route submissions
  • 505(b)(2) strategy planning (US)
  • UK Legal Representative / EU affiliate coordination

Why Pharmegic

The partner who delivers science-first, lean, and globally aligned solutions.

Integrated Expertise

Integrated CMC, R&D, and Regulatory expertise

Deep Focus

Deep focus on small molecules & complex injectables

Lean & Science-First

Lean, science-first execution with global alignment

Partnerships & Transparency

CRO/CDMO partnerships for rapid mobilization Transparent costing, milestone-driven delivery

Ready to accelerate your product development journey?

Whether you need CMC, R&D, or Regulatory support — we’re here to deliver science-first, globally aligned solutions.
Contact our Team