Just because a specific parameter, attribute, or scenario is not explicitly mentioned in a guidance document does not mean that grey area is exempted from control. The responsibility lies with us, as professionals, to apply sound judgement and ensure quality and compliance in those areas.

NewColor is sometimes a Critical Quality Attribute — measure it online. Access to further details provided on request.
Global Pharmaceutical Services

Precision-Driven partners in your Business Development Journey.

Xpertee Pharma Services delivers end-to-end API & raw material procurement, GMP & regulatory excellence, advanced characterization and microbiological, stability & analytical testing — engineered for regulators, trusted by manufacturers.Your one-stop shop for all your business development needs.

US FDA · EU EMA
Regulatory alignment
40+ Countries
Global sourcing network
ISO 17025
Accredited testing
New

Unlock Clearer Business DecisionsOperational Dashboard

From data noise to confident action — reports tell you what happened; this dashboard tells you what to do next.

Customized live operational intelligence

Agility

Avoid inventory shortfalls and buildups with real-time stock visibility and early signals.

No Surprises

Stay ahead of risks with live signals so that you are never caught off guard.

Consistent Growth

Build confidence into every decision. When the whole organization sees the same truth, execution becomes coherent and scalable.

Your Data, One Dashboard

Five signals. One view. Zero guesswork.

Every dimension that moves your business — sourced, correlated and displayed live in one operational canvas.

Inventory

Real-time stock monitoring to avoid over- or under-stocking.

Sales

Performance by market, channel, customer and product line.

Pricing

Dynamic rates, margin health, and competitive pressure.

Market Dynamics

Demand signals and competitive moves in one place.

Compliance Risk

Compliance risk and policy changes before they hit.

Instant Operational Insights

Traffic-light clarity for every decision.

Know exactly where to focus. Green means smooth. Amber means watch. Red means act now.

Green

On track

Everything running as planned. No action needed — maintain course and protect the upside.

Amber

Watch closely

Early warning signals detected. Investigate and act before small issues become costly problems.

Red

Act now

Critical thresholds breached. Prioritize response now to protect revenue, stock or compliance.

Ready to see your operations in one clear view?

Talk to our team about a tailored dashboard for your business.

Talk to Us
What We Do

Eight disciplines. One integrated pharma services partner.

Every engagement is delivered by pharmacists, chemists, quality auditors and regulatory experts with deep hands-on regulated-industry experience.

Procurement Support

Strategic sourcing of APIs, raw materials and formulations through a transparent agency model.

  • Active Pharmaceutical Ingredients (APIs)
  • Raw materials & intermediates
  • Formulations & finished dosages
  • Agency-model supply chain

Technical Sales & Business Development

We handle the technical complexities of your business relationships so you can focus on commercial success.

  • Customer & vendor qualification governance
  • Site Assessment & Quality Agreements
  • Sampling, complaints & technical inquiry management
  • Expert-led site audits & Gemba walks

Strategic Service Support

The technical backbone for your manufacturing and laboratory operations.

  • Qualified working standards (API supplied by user)
  • Formulation & analytical method troubleshooting
  • Dissolution profiling & bioavailability optimisation
  • Impurity identification, qualification & control

Advanced Characterization

State-of-the-art analytical characterization for APIs, excipients and finished products.

  • Particle size — Malvern Mastersizer
  • Solid state — PXRD, DSC, TGA
  • Chromatography — HPLC, GC, UV advisory
  • Mass spec — LCMS, GCMS, ICPMS

Microbiological Testing

Sterility, bioburden and endotoxin testing to safeguard product quality.

  • Sterility testing (viable microorganism absence)
  • Bioburden — total microbial count pre-sterilization
  • Endotoxin (LPS) detection for injectables
  • Compendial protocols (USP / EP / IP)

Comprehensive Stability Studies

Real-time and accelerated stability testing for APIs and formulations.

  • Real-time & accelerated stability testing
  • State-of-the-art ICH-compliant chambers
  • API + formulation sample analysis
  • Regulatory-ready stability data packages

Regulatory & Facility Excellence

Navigate global regulatory markets with partners who understand the fine print.

  • Global dossier management — US FDA, EU, Japan, Korea, Middle East
  • SOP architecture for on-site manufacturing
  • USFDA, EU-GMP, MHRA audit-readiness consultancy
  • QC lab specialist coaching

Quality Systems & Expert Training

Building a culture of quality through rigorous investigation and professional development.

  • Incidents, deviations, CAPA & change control
  • OOS / OOC investigation expertise
  • Data integrity training — modern expectations
  • Core GMP & audit-strategy workshops
Scientist in sterile laboratory corridor
About Xpertee

A quiet, credible force behind global pharma supply chains.

We help pharmaceutical manufacturers, biotechs and generics companies secure quality raw materials, stay ahead of regulatory expectations, and validate every step of their process — from bench to batch release.

Under the leadership of Manoj Kumar (Director), our team combines technical depth with operational discipline — so you get answers grounded in science, defensible in front of auditors, and delivered on time.

  • Global sourcing — APIs, raw materials & formulations
  • USFDA, EU-GMP, MHRA audit-readiness expertise
  • Advanced characterization — Malvern, PXRD, DSC, TGA, LCMS
  • Stability, microbiological & impurity control programs
  • Global dossier management across regulated markets
  • QMS investigation, CAPA & data-integrity training
How We Work

A methodical process, delivered without drama.

Every project runs through the same disciplined workflow — so you know what to expect, and regulators know what to trust.

01

Discovery & Scoping

We map your regulatory obligations, timelines and quality gaps in a structured intake session.

02

Qualification & Design

For sourcing: vendor shortlist & DMF review. For compliance: protocol, SOP and audit plan design.

03

Execution

On-site audits, cGMP readiness, sample dispatch, HPLC/GC testing and documentation — traceable end-to-end.

04

Reporting & Follow-through

Regulator-ready reports, CAPA support, batch release documentation and continuous improvement roadmap.

Standards We Work To

Aligned with the frameworks that matter.

We operate against globally recognised pharmaceutical quality frameworks and continuously update our protocols as guidance evolves.

US FDA
21 CFR Part 210/211 alignment
EU EMA
EudraLex Vol. 4 GMP practices
WHO GMP
Prequalification-ready systems
ICH Q7 / Q9 / Q10
Quality risk & lifecycle
ISO 17025
Testing lab accreditation aligned
MHRA / PIC/S
Inspection-ready documentation
Contact

Talk to a pharma services specialist.

Share your project brief — sourcing need, audit scope, compliance concern, characterization requirement or stability program — and we’ll respond within one business day.

Point of contact
Manoj Kumar
Director, Xpertee Pharma Services Private Limited
Head office
NGJ-112, DLF New Town Heights, Sector 90, Gurgaon 122505, Haryana, India
Mobile
+91 98719 91523
WhatsApp
+91 74284 11522
Email
Catalyst@xpertee.in

By submitting, you agree to be contacted about your inquiry. We respect confidentiality.