VSP Pharma Services

Process R&D

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

Request a 30-minute scoping call Download brochure PDF · 2 pages

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.

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

How we engage

Support shaped around your team.

01 / Diagnostic

Define the starting point.

A short, fixed-scope assessment, such as a GMP gap review or route-feasibility study, with a written report and recommendations.

02 / Project

Work to a clear deliverable.

Defined deliverables and timeline: a validation protocol package, a process recommendation report or a transfer plan.

03 / Ongoing support

Keep expertise close.

Retainer or embedded experts for audit programmes, remediation, commissioning and plant start-up.

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