R&D / Formulation
Pharmaceutical formulation development support
Structuring an immediate-release tablet development so trial data leads to a scalable, documented formulation.
Illustrative use caseAdvanced Thinking Across the Pharmaceutical Lifecycle
Connecting pharmaceutical research, development, manufacturing, quality, technology, digital transformation and AI to practical project execution.
- Research
- Develop
- Manufacture
- Assure quality
- Digitalise
- Apply AI
From concept to executionWe identify, coordinate, manage and execute the right capabilities across the lifecycle, based on project requirements.
One project partner across science, manufacturing, quality, technology and AI
Pharmaceutical projects rarely sit in one discipline. A formulation change touches analytical methods, manufacturing, validation, regulatory filings — and increasingly, software and data.
Since 2019, DGXPComplianceLab has supported pharmaceutical quality and compliance work from Hyderabad. Today we bring those pieces together through DGXPComplianceLab-led project execution: our internal team, specialised experts, technology partners, research organisations, manufacturing partners, laboratories and external pharmaceutical service providers — selected for each project, coordinated as one.
How we work13Lifecycle stages covered, discovery to AI
12Capability areas
15Countries and regions in our collaboration reach
2019Established in Hyderabad — two offices today
Explore the pharmaceutical lifecycle
Select a stage to see what happens there, the typical activities, and where our capabilities fit.
Stage 1 of 13
Discovery
Identifying a therapeutic need, target or product opportunity, and deciding whether it is worth developing.
- Opportunity and literature assessment
- Reference product and patent landscape
- Target product profile (first draft)
Stage 2 of 13
Research
Building the scientific understanding of the molecule and the product concept.
- API characterisation
- Pre-formulation studies
- Feasibility experiments
Stage 3 of 13
Formulation Development
Designing a dosage form that delivers the drug reliably and can be manufactured consistently.
- Prototype formulations
- Excipient selection
- Optimisation using DoE
Stage 4 of 13
Analytical Development
Developing and validating the methods that prove identity, strength, purity and performance.
- Method development
- Method validation (ICH Q2)
- Specification setting
Stage 5 of 13
Process Development
Understanding the process well enough to scale it and control it.
- Critical process parameters
- Scale-up studies
- Process risk assessment
Stage 6 of 13
Clinical / CRO
Generating the study evidence a product needs, through contract research organisations.
- Study scoping
- CRO coordination
- Data and report review
Stage 7 of 13
Technology Transfer
Moving product and process knowledge to the site that will manufacture it.
- Transfer protocol
- Knowledge package
- Exhibit / validation batches
Stage 8 of 13
Manufacturing
Producing batches consistently under GMP at a qualified site.
- CMO / CDMO manufacturing
- Process validation
- Batch record review
Stage 9 of 13
Quality & Compliance
Making sure every batch, record and system meets the required standard.
- Deviation and CAPA
- Change control
- Computerised system validation
Stage 10 of 13
Regulatory
Preparing and maintaining the information regulators need to approve and oversee a product.
- CMC documentation inputs
- Change impact assessment
- Inspection readiness
Stage 11 of 13
Commercialisation
Supplying the market reliably: packaging, release, distribution and lifecycle management.
- Packaging and serialisation
- Supply continuity
- Annual product review
Stage 12 of 13
Digital Transformation
Replacing paper and disconnected tools with controlled digital workflows.
- eQMS, LIMS, DMS, LMS
- Electronic batch records
- Digital validation
Stage 13 of 13
AI & Continuous Improvement
Using data and AI — under governance — to learn from every batch, test and document.
- AI use cases
- AI governance and validation
- Performance monitoring
Capability explorer
What each capability is, where it fits, and an example of the work involved.
Pharmaceutical Research & Development
- What it is
- Structured research and development support that moves a product idea through pre-formulation, formulation, analytical and process work to a transfer-ready package.
- Where it fits
- Research → Formulation Development → Analytical Development → Process Development → Technology Transfer
- Typical activities
- Product research, Pre-formulation, Formulation development, Analytical development, Process development
- Example project
- Pharmaceutical formulation development support Illustrative
- Related technologies
- Quality by Design (ICH Q8), Design of Experiments, Risk assessment (ICH Q9), HPLC / UPLC methods, Dissolution profiling
- Related services
- Formulation Development, CRO, Contract Laboratory, CMO / CDMO
Product & Formulation Development
- What it is
- From prototype to a robust, scalable formulation: dosage-form design, optimisation and the process knowledge that makes a product manufacturable.
- Where it fits
- Formulation Development → Analytical Development → Process Development → Technology Transfer
- Typical activities
- Tablets, Capsules, Oral liquids, Topical formulations, Sterile products
- Example project
- Pharmaceutical formulation development support Illustrative
- Related technologies
- Fluid bed processing, High-shear granulation, Roller compaction, Tablet compression & coating, Encapsulation
- Related services
- Research & Development, External Manufacturing, Contract Laboratory
External Manufacturing
- What it is
- Identifying, evaluating and coordinating qualified external manufacturers so your product is made where the technical, quality and regulatory fit is right.
- Where it fits
- Technology Transfer → Manufacturing → Quality & Compliance → Commercialisation
- Typical activities
- Product and process assessment, Manufacturer identification, Technical evaluation, Quality and compliance assessment, Technology transfer
- Example project
- External manufacturing partner identification Illustrative
- Related technologies
- Supplier qualification, Quality agreements, Technology transfer protocols, Process validation (Stage 1–3), Batch record review
- Related services
- CMO / CDMO, Regulatory & Quality, Contract Laboratory
CMO / CDMO Services
- What it is
- Contract manufacturing and contract development-and-manufacturing support, coordinated through qualified partner organisations.
- Where it fits
- Formulation Development → Process Development → Technology Transfer → Manufacturing → Quality & Compliance
- Typical activities
- Scope definition, Partner evaluation, Development, Scale-up, Technology transfer
- Example project
- CDMO product development coordination Illustrative
- Related technologies
- Oral solid dosage trains, Sterile / aseptic processing, Lyophilisation, Bioprocess equipment, Process validation
- Related services
- External Manufacturing, Formulation Development, Regulatory & Quality
CRO / Contract Research
- What it is
- Research and development studies coordinated with contract research organisations, with DGXPComplianceLab managing scope, data and documentation.
- Where it fits
- Research → Analytical Development → Clinical / CRO → Regulatory
- Typical activities
- Research support, Development studies, Analytical research, Clinical research support, Bioanalytical support
- Example project
- CDMO product development coordination Illustrative
- Related technologies
- GLP / GCP principles, Study protocols & reports, Electronic data capture, Bioanalytical method validation (ICH M10), Data integrity (ALCOA+)
- Related services
- Contract Laboratory, Research & Development, Regulatory & Quality
Contract Laboratory Services
- What it is
- Analytical testing, method work and stability programmes arranged with contract laboratories, with clear lines between what we do and what partners perform.
- Where it fits
- Analytical Development → Quality & Compliance → Manufacturing
- Typical activities
- Analytical testing, Method development, Method validation, Stability studies, Microbiology
- Example project
- Contract laboratory testing programme Illustrative
- Related technologies
- HPLC / GC, Dissolution, Karl Fischer, UV / IR spectroscopy, Microbiological methods
- Related services
- CRO, Digital Transformation, Regulatory & Quality
Technology Design, Build, Test & Verify
- What it is
- Engineering pharmaceutical technology the way it will be inspected: requirements first, designed and built to them, then tested and verified with evidence.
- Where it fits
- Process Development → Manufacturing → Quality & Compliance → Digital Transformation
- Typical activities
- PLC, HMI, SCADA, Automation, Manufacturing systems
- Example project
- PLC / HMI / SCADA design & verification Illustrative
- Related technologies
- GAMP 5 (2nd ed.), ISA-88 / ISA-95, URS / FS / DS, FAT / SAT, IQ / OQ / PQ
- Related services
- Digital Transformation, Pharmaceutical Software, Regulatory & Quality
Pharmaceutical Digital Transformation
- What it is
- Converting paper-based and fragmented pharmaceutical processes into controlled, connected digital workflows that stay compliant.
- Where it fits
- Manufacturing → Quality & Compliance → Digital Transformation → AI & Continuous Improvement
- Typical activities
- Digital quality, eQMS, LIMS, DMS, LMS
- Example project
- eQMS workflow digitisation Illustrative
- Related technologies
- eQMS, LIMS, DMS, LMS, MES
- Related services
- Pharmaceutical Software, Technology & Engineering, AI for Pharma
Pharmaceutical Software Solutions
- What it is
- Software designed around pharmaceutical workflows — requirements, workflow design, validation and documentation included from the start.
- Where it fits
- Quality & Compliance → Regulatory → Digital Transformation → AI & Continuous Improvement
- Typical activities
- Software requirements, Software design, Workflow design, Validation, Quality systems
- Example project
- Pharmaceutical document management system Illustrative
- Related technologies
- PHP / MariaDB, Role-based access control, Audit trails, Electronic signatures, 21 CFR Part 11
- Related services
- Digital Transformation, AI Governance & Validation, Regulatory & Quality
AI Across the Pharmaceutical Lifecycle
- What it is
- Practical AI where it helps pharmaceutical work — research, development, manufacturing, quality, regulatory, laboratory and supply chain — governed from day one.
- Where it fits
- Research → Manufacturing → Quality & Compliance → Regulatory → AI & Continuous Improvement
- Typical activities
- Use-case discovery, Data readiness assessment, Solution design, Build and integration, Validation
- Example project
- AI-based SOP knowledge assistant Illustrative
- Related technologies
- Large language models, Retrieval-augmented generation, Machine learning, Statistical process control, Document intelligence
- Related services
- AI Governance & Validation, Digital Transformation, Pharmaceutical Software
AI Governance & AI Validation
- What it is
- AI is not implemented simply because it is available. In pharmaceutical work it needs an intended use, a risk assessment, validation and lifecycle control.
- Where it fits
- Quality & Compliance → Regulatory → AI & Continuous Improvement
- Typical activities
- Intended use, Risk assessment, Data assessment, Model assessment, Human oversight
- Example project
- AI validation framework Illustrative
- Related technologies
- GAMP 5 (2nd ed.), ISPE GAMP AI guidance, EU Annex 11, EU AI Act awareness, ICH Q9(R1)
- Related services
- AI for Pharma, Regulatory & Quality, Pharmaceutical Software
Regulatory, Quality & Documentation Practices
- What it is
- GxP compliance, validation and documentation practices that make pharmaceutical work traceable, reviewable and inspection-ready.
- Where it fits
- Quality & Compliance → Regulatory → Manufacturing → Digital Transformation
- Typical activities
- GxP gap assessments, Computerised system validation, Data integrity programmes, Quality risk management, Documentation practices
- Example project
- eQMS workflow digitisation Illustrative
- Related technologies
- GxP, GMP, GLP, GCP, GDP
- Related services
- AI Governance & Validation, Technology & Engineering, Pharmaceutical Software
How a pharmaceutical activity evolves: process → digital → software → data → AI
One example — batch record review — shows our philosophy. Each step builds on the one before, and governance closes the loop.
Step 1 — Traditional activity
Manual batch record review
QA reviewers read every page of a paper batch record, checking entries, calculations and signatures by hand. Review takes days, and most findings are documentation errors rather than quality issues.
What changes
Paper, manual checks, late error detection
Paper, manual checks, late error detection
Maturity
Step 2 — Process improvement
Structured review workflow
The review is standardised: a checklist, defined critical entries, and a route for correcting documentation errors at source. Same paper — less variability.
What changes
Checklists, defined critical steps
Checklists, defined critical steps
Maturity
Step 3 — Digital process
Electronic batch record
Instructions are executed on screen. The system enforces sequence, checks ranges and captures who did what, when — so many paper errors can no longer occur.
What changes
Enforced sequence, audit trail, e-signatures
Enforced sequence, audit trail, e-signatures
Maturity
Step 4 — Software
Automated review & workflow
Review by exception: the system flags only out-of-range values, deviations and incomplete steps. QA reviews the exceptions, not every field.
What changes
Exception rules, routing, notifications
Exception rules, routing, notifications
Maturity
Step 5 — Data
Structured manufacturing data
Every parameter and result is stored as structured data, ready for trending across batches, equipment and products.
What changes
Data model, historian, dashboards
Data model, historian, dashboards
Maturity
Step 6 — AI
AI-assisted intelligence
AI highlights unusual trends, links a new deviation to similar past events and summarises batch history for the reviewer.
What changes
Similarity search, trend detection, summaries
Similarity search, trend detection, summaries
Maturity
Step 7 — Governance
Validation, risk & human oversight
Each AI function has an intended use, risk assessment, validation evidence and monitoring. The qualified person still decides.
What changes
Risk-based validation, change control
Risk-based validation, change control
Maturity
Our project execution model
Every engagement follows the same eight steps, scaled to the size and risk of the project.
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01
Understand
Understand business and technical requirements.
-
02
Assess
Assess scientific, technical, regulatory and operational requirements.
-
03
Design
Design the appropriate solution.
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04
Identify
Identify appropriate internal and external capabilities and partners.
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05
Execute
Coordinate and execute the project.
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06
Verify
Test, verify, qualify or validate where applicable.
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07
Document
Create technical, quality and regulatory documentation.
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08
Improve
Monitor, optimise and continuously improve.
Partner ecosystem
Pharmaceutical projects often need several specialised capabilities. We bring the right ones together around your requirement.
Client requirement
DGXPComplianceLab- R&D
- Manufacturing
- CMO / CDMO
- CRO
- Laboratory
- Technology
- Automation
- Software
- AI
- Regulatory
- Quality
Integrated project execution
Projects & use cases
Illustrative use cases showing how requirements become executed, documented and verified work.
Manufacturing / CMO
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Illustrative use case
Automation / Quality
PLC / HMI / SCADA design & verification
Specifying and verifying the control system of a new filling machine before GMP use.
Illustrative use caseSoftware / Quality / Digital
Pharmaceutical document management system
A controlled document lifecycle with review, approval, effective dates and archive.
Illustrative use case
AI / Quality / Manufacturing
AI deviation investigation support
Surfacing similar past deviations and likely contributing factors to support investigators.
Illustrative use caseAI / Quality / Software
AI validation framework
A validation approach for AI-enabled GxP applications, from intended use to monitoring.
Illustrative use caseIndustries we support
Organisations across the pharmaceutical and life-science value chain.
- Pharmaceutical
- Biotechnology
- API
- Formulations
- CDMO
- CMO
- CRO
- Contract Laboratories
- Medical Devices
- Healthcare Technology
- Life Sciences
- Pharmaceutical Engineering
- Laboratory Technology
Global collaboration, Hyderabad base
Our registered office and R&D services office are in Hyderabad. Project and collaboration activities may involve organisations across these regions, depending on each project’s requirements:
- India
- United States
- United Kingdom
- Germany
- France
- Switzerland
- Ireland
- Netherlands
- Belgium
- Singapore
- Japan
- Australia
- Canada
- UAE
- Saudi Arabia
Pharmaceutical industry practical discussions
How pharmaceutical projects actually work — concept, example, process, documentation, technology and quality.
How does a pharmaceutical product move from research to manufacturing?
The stages, decisions and documents that carry a product from the laboratory bench to routine GMP production.
How is a CMO/CDMO selected for a pharmaceutical project?
Selection criteria, evaluation steps and the documents that make the choice defensible.
What information is required before starting a technology-transfer project?
The knowledge package a receiving site needs before the first batch.
Build the future of pharmaceutical innovation
Explore opportunities across pharmaceutical science, technology, digital transformation and AI.
- Graduate, fresher and internship routes
- Experienced professionals and subject matter experts
- Technology, data and AI roles in a GxP context
Have a research, manufacturing, technology or digital requirement?
Tell us what you need. We will discuss scope, the capabilities involved and how the project could be executed.