KPHB Colony, Hyderabad, India Bulk drugs · Intermediates · Specialty chemicals
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Technical consulting, from route to release.

Process R&D, analytical, quality and manufacturing expertise for pharma manufacturers, backed by 28 years inside the pharma supply chain.

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Expertise beyond sourcing

Specialists matched to your problem.

Developing a process, building an analytical method, preparing a laboratory for audit or scaling a product into the plant: our specialists help you define the next steps.

We work as advisers. We design the studies and review the data. Your team or a laboratory of your choice carries them out.

Our services

Five areas of technical expertise.

Process R&D

Clear route and process recommendations for APIs, key starting materials and advanced intermediates.

Guidance referenced

ICH Q8, Q9, Q11, Q3A/B/C/D, M7

How we can help

  • Route scouting and patent review, ending in a ranked route recommendation
  • Proposed study designs, including DoE plans, for your team or a CRO to execute
  • Paper-based impurity-risk assessment, including mutagenic-impurity and nitrosamine evaluation, with control strategy
  • Solid-form and particle-size strategy: what to screen, why, and with which partners
  • Review of your development data; process-description outline for DMF or dossier filing
  • Cost-of-goods reduction and scale-up risk assessment
Discuss this service

Analytical Method Development

A sound analytical strategy, with validation and transfer plans ready for your laboratory to execute.

Guidance referenced

ICH Q2(R2), Q14, Q6A; IP, USP, Ph. Eur.

How we can help

  • Analytical target profile and method-selection recommendation for each material
  • Validation protocol design with acceptance criteria and rationale
  • Review of validation reports; method transfer protocol and acceptance criteria
  • Impurity-control strategy for residual solvents, elemental and genotoxic impurities
  • Specification setting and justification
  • Reference and impurity standard strategy
Discuss this service

Quality Control

A QC function whose procedures and data practices stand up to inspection.

Guidance referenced

21 CFR 210/211, EU GMP Ch. 6 and Annex 11, GAMP 5, WHO TRS

How we can help

  • Review of QC organisation, workflow and responsibilities
  • Data integrity gap assessment of procedures, records and systems (ALCOA+, 21 CFR Part 11)
  • OOS and OOT investigation procedure, review of closed cases, and coaching
  • Training curriculum and competency framework for analysts
  • Reference standard, reagent and sample management procedures
  • Laboratory SOP and record redesign
Discuss this service

Quality Assurance

A quality system that is compliant on paper and in practice, with audit readiness built in.

Guidance referenced

ICH Q7, Q9, Q10; 21 CFR 210/211, EU GMP, Schedule M

How we can help

  • GMP gap assessment and mock inspection (FDA, EU, WHO, Schedule M)
  • QMS build or remediation: change control, deviation, CAPA, complaints, APR
  • Supplier and vendor qualification, audit programmes, remote audits
  • DMF and dossier quality sections; responses to inspection observations
  • Internal auditor training and quality-culture programmes
Discuss this service

Manufacturing and Production Support

Well-planned transfer from development to plant, with fewer deviations and better yield.

Guidance referenced

ICH Q8, Q10, Q11; EU GMP Annex 15; FDA process validation guidance

How we can help

  • Technology transfer packages and site-readiness assessments
  • Scale-up strategy and equipment-fit assessment
  • Process validation strategy and protocol design; cleaning validation approach
  • Yield and cost improvement recommendations from batch record and deviation review
  • Continuous process verification plan: what to monitor and how to act
Discuss this service
How we engage

Support shaped around your team.

Who we work with
  • API and intermediate manufacturers
  • Formulation companies
  • Biotech and virtual pharma
  • Contract manufacturers
  • Testing laboratories
  • Overseas buyers qualifying Indian suppliers
A connected approach

One accountable point of contact.

  • Specialists matched to your technical problem
  • Technical work joined to supplier identification, qualification and second-source development
  • Documentation built to ICH, GMP and pharmacopoeial expectations
  • Confidential, independent advice with clear scope and ownership of your data and IP
Let’s define the scope

What does your team need to solve?

Start with a 30-minute conversation about your process, laboratory, quality system or manufacturing challenge.

Request a scoping call