Est. 2019 · Pharmaceutical research, development, technology & contract services · Hyderabad, India sales@dgxpcompliancelab.com Careers

Capability

Pharmaceutical Research & Development

Structured research and development support that moves a product idea through pre-formulation, formulation, analytical and process work to a transfer-ready package.

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Open-plan laboratory with scientists at benches and a data display
Scientists working with laboratory reactors and data monitors

What we do

We plan and coordinate development work so that each stage produces the data the next stage needs. That means defining the target product profile early, agreeing which studies are critical, and keeping development reports in a form that manufacturing, quality and regulatory teams can use later.

Laboratory and pilot-scale studies are carried out by qualified research partners selected for the dosage form and technology involved. DGXPComplianceLab frames the development plan, reviews the data and keeps the documentation trail coherent from first experiment to technology transfer.

Where it fits in the pharmaceutical lifecycle

Typical activities

Each activity shows who performs it. We do not claim facilities we do not own.

DGXP-led Led by the DGXPComplianceLab team Partner-coordinated Performed by a qualified partner, coordinated by us

  • Product research

    DGXP-led

    Reference product characterisation, literature and patent landscape, target product profile.

  • Pre-formulation

    Partner-coordinated

    API physicochemical characterisation, solubility, polymorphism and excipient compatibility studies.

  • Formulation development

    Partner-coordinated

    Prototype design, trial batches and optimisation against critical quality attributes.

  • Analytical development

    Partner-coordinated

    Method development for assay, related substances, dissolution and identification.

  • Process development

    Partner-coordinated

    Unit-operation selection, critical process parameters and design-space thinking.

  • Packaging considerations

    DGXP-led

    Primary pack selection, moisture/light protection and compatibility rationale.

  • Stability-related activities

    DGXP-led

    Protocol design aligned to ICH Q1A(R2), pull schedules and trend review.

  • Scale-up support

    DGXP-led

    Scale-up rationale, equipment equivalence and engineering batch planning.

  • Technology transfer

    DGXP-led

    Transfer protocols, knowledge packages and receiving-site readiness.

  • Product lifecycle development

    DGXP-led

    Post-approval changes, line extensions and continuous improvement studies.

Illustrative project example: oral solid dosage formulation development

  1. 1Requirement
  2. 2Research
  3. 3Formulation
  4. 4Analytical
  5. 5Process development
  6. 6Scale-up
  7. 7Documentation
  8. 8Manufacturing partner
  9. 9Quality review

Illustrative project example — not a description of a specific client project.

Technologies and processes

  • Quality by Design (ICH Q8)
  • Design of Experiments
  • Risk assessment (ICH Q9)
  • HPLC / UPLC methods
  • Dissolution profiling
  • Stability chambers (ICH zones)
  • Electronic lab notebooks

Example projects

Illustrative use cases showing how this capability is typically applied.

All projects

Our project execution model

Every engagement follows the same eight steps, scaled to the size and risk of the project.

  1. 01

    Understand

    Understand business and technical requirements.

  2. 02

    Assess

    Assess scientific, technical, regulatory and operational requirements.

  3. 03

    Design

    Design the appropriate solution.

  4. 04

    Identify

    Identify appropriate internal and external capabilities and partners.

  5. 05

    Execute

    Coordinate and execute the project.

  6. 06

    Verify

    Test, verify, qualify or validate where applicable.

  7. 07

    Document

    Create technical, quality and regulatory documentation.

  8. 08

    Improve

    Monitor, optimise and continuously improve.

Related services

Formulation Development

From prototype to a robust, scalable formulation: dosage-form design, optimisation and the process knowledge that makes…

CRO

Research and development studies coordinated with contract research organisations, with DGXPComplianceLab managing scop…

Contract Laboratory

Analytical testing, method work and stability programmes arranged with contract laboratories, with clear lines between …

CMO / CDMO

Contract manufacturing and contract development-and-manufacturing support, coordinated through qualified partner organi…

Frequently asked questions

Do you run your own development laboratory?

Laboratory and pilot work is performed by qualified partner organisations selected for the product and technology. DGXPComplianceLab leads planning, data review, documentation and coordination.

What do you need to start a development discussion?

The target product or reference product, intended market(s), dosage form, expected scale and any existing development data. A short requirement note is enough for a first discussion.

Can you pick up a project that is already in progress?

Yes. We start with a gap assessment of the existing data and reports, then agree what has to be repeated, completed or documented.

Discuss a research & development requirement

Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.

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