Find the right service for your product

Use this when you need a product approved, a licence renewed, or an audit passed.

What you get

• A regulatory route for each market you want to reach
• CDSCO filings, plus support after approval (changes, renewals and label updates)
• US FDA strategy for 510(k), De Novo, IND, NDA and BLA routes

Covers

CDSCO (India) · US FDA · EU MDR · Medical Devices Rules, 2017 (India)

Use this when an inspection or client audit is coming, or you want to know where you stand.

What you get

• An audit plan agreed with you before we start
• Mock inspections that follow how a regulator works
• Audits of your sites, systems and suppliers

Covers

CDSCO (India) · US FDA · Good practice rules

Use this when you hold a marketing licence and must track and report side effects.

What you get

• A safety system set up for your products: the PSMF and the SOPs (written step-by-step procedures)
• Case intake from patients, doctors, pharmacists and carers
• Case processing and medical review of each report

Covers

CDSCO (India) · PvPI · MvPI · ICH safety guidelines · EU MDR

Use this when you need a study in people to prove your product is safe and works.

What you get

• Protocol writing and a feasibility check (can this study be done, where and how fast)
• Ethics committee and CDSCO submissions
• Site selection, set-up and start-up

Covers

CDSCO (India) · New Drugs and Clinical Trials Rules, 2019 · Medical Devices Rules, 2017 · ICH Good Clinical Practice (GCP) · Ethics committees

Use this when you need stability, packaging, transport or batch release testing.

What you get

• Stability studies at ICH conditions: long-term, intermediate, accelerated and light exposure
• Packaging validation
• Transport validation, including cold chain studies with temperature loggers

Covers

ISO/IEC 17025 · ICH Q1A(R2) and Q1B · ICH Q2(R2) · USP, EP, IP and JP · ISO 10993

Use this when you need preservative, sterility, bioburden or antibacterial testing.

What you get

• Preservative efficacy test (PET) to USP <51>, EP 5.1.3 or IP. We add germs to your product and check the preservative kills them over 28 days.
• Sterility test to USP <71>. We check that a product sold as sterile has no living microbes in it.
• Bioburden and microbial limit tests to USP <61> and <62>. We count the microbes in a product, and check for specific harmful ones.

Covers

USP <51>, EP 5.1.3 and IP · USP <71> · USP <61> and <62> · ISO 22196 and JIS Z 2801 · AATCC 100 · EN 1276, EN 13697 and AOAC methods

Use this when you need usability studies or child-resistant packaging tests.

What you get

• A human factors and usability study plan, built around your users and how they will use the product
• Formative usability studies (early studies that shape the design)
• Summative usability studies (a final study that shows the design is safe to use)

Covers

ISO/IEC 17025 · IEC 62366-1 · ISO 8317

Use this when you need evidence from everyday use, after or alongside a trial.

What you get

• Observational studies: we watch what happens to patients in normal care, without changing their treatment
• Patient registries: an organised record of patients with a condition or product, followed over time
• Hospital data partnerships, set up through our hospital network

Covers

CDSCO (India) · Ethics committees (IEC) · MedDRA

Use this when your approval is in sight and you need a launch plan.

What you get

• A go-to-market plan linked to your approval timeline
• Product placement and commercial strategy
• Help finding and setting up distributors

Covers

NPPA (India) · DPCO (India) · CoPP · CDSCO (India)

Use this when you have an idea and need a clear first step.

What you get

• A review of the opportunity and of other products in the field
• A roadmap for the science and clinical work
• A regulatory gap assessment: what your evidence shows, and what is missing for approval

Covers

CDSCO (India) · Medical Devices Rules, 2017 (India) · US FDA and EU MDR