Spectratix Pharma Pvt. Ltd. · Pune, India

From molecule to inspection-ready. One partner for every regulated science.

Consultancy, testing, regulatory, audit, research, AI and training services for pharmaceuticals, biopharma, biotechnology, medical devices, semiconductors, and food, water, environmental and soil testing. Backed by a team with more than 22 years of hands-on industry experience.

FOSTERING INNOVATION, BUILDING EXPERTISE

SAMPLE: Spectratix capability profileDETECTOR: experience
6 peaks resolved · Rs > 2.0Method: ICH Q2(R2) compliant
Audit experience with
USFDAUnited States EU GMPEuropean Union MHRAUnited Kingdom ANVISABrazil WHOGMP · PQ CDSCOIndia
22+years of team experience in industry, QA, QC, R&D and regulatory
25+national and international clients
1500+students and professionals trained
100+training programmes delivered
3patents to the team's name
6+regulatory agencies' audits faced and supported
Sectors we serve

Nine regulated industries, one standard of science.

Wherever an analytical result, a validated process or a regulatory submission decides whether a product ships, we can help. Each tile lists the frameworks we work to.

01Rx
Ph

Pharmaceuticals

APIs, formulations, analytics, validation and dossiers.

ICH · USFDA · CDSCO
02mAb
Bp

Biopharmaceuticals

Biologics characterisation, bioanalytics and CMC.

ICH Q5 · Q6B · M10
03DNA
Bt

Biotechnology

Research support, bioinformatics and lab set-up.

GLP · ISO 17025
04IVD
Md

Medical devices

Technical files, QMS, biocompatibility and E&L.

ISO 13485 · MDR 2017
05ppt
Sc

Semiconductors

Trace-metal analytics, ultrapure water and process chemicals.

ICP-MS · SEMI grades
06FSS
Fd

Food testing

Contaminants, residues, nutrition and lab compliance.

FSSAI · Codex
07H₂O
Wt

Water testing

Drinking, purified and WFI quality programmes.

IS 10500 · USP <643>
08Env
En

Environmental testing

Effluent, emissions and ambient monitoring.

CPCB · SPCB norms
09NPK
Sl

Soil testing

Nutrients, heavy metals and pesticide residues.

Soil health · contamination
10?
+

Your sector

Allied, nutraceutical, cosmetic or research? Ask us.

Tell us the problem →
Service catalogue

Everything from API production to AI, under one roof.

Filter by area or search for what you need: a molecule, a test, a guideline, a document. Every engagement starts with an NDA and a clear scope.

Where a study needs accredited laboratory or animal facilities, we design the programme, place the work with qualified partner facilities and review every data package before it reaches you.

Who we serve

Start where you are.

Industry teams, global clients, working professionals, institutions and students each come to us with different questions. Pick yours.

Why Spectratix

22+ years on the shop floor, in the lab and in front of inspectors.

Our consultants have run QC labs, written the dossiers, faced the inspections and closed the observations. That is the experience you get on every project.

End-to-end, single partner

Development, analytics, validation, quality, regulatory and training with one point of contact.

Compliance-first deliverables

Every document is written to current ICH, USFDA, EMA, MHRA, WHO and CDSCO expectations.

Practical execution

Solutions that work in the lab and on the shop floor, not only on paper.

Confidential and reliable

NDA-first engagements, clear ownership and milestone-based delivery.

Industry meets academia

Advisors from industry and universities, so research is rigorous and training is job-ready.

Cost-effective quality

Senior expertise through flexible models that fit national and global budgets.

PharmaGyan Academy

1500+ people trained through 100+ programmes.

Our education arm turns industry experience into job-ready skills for students, professionals and corporate teams, with hands-on instrument training wherever the subject demands it.

Certificate programmes, workshops, faculty development and corporate training, delivered online, on campus and on-site.

Certificate coursesHands-on HPLC workshopsWebinarsFaculty developmentCorporate in-houseInternshipsMock interviewsNational quiz
Students in lab coats during hands-on HPLC training
Enrol in a programme ↗
QA

Pharmaceutical Quality Systems

QMS, GMP compliance, deviations, CAPA, change control and data integrity.

RA

Regulatory Affairs

Drug approval pathways, CTD/eCTD dossiers and global submission standards.

CR

Clinical Research

Trial design, ethics, ICH-GCP and the end-to-end drug development process.

AI

Artificial Intelligence in Pharma

AI and data methods for drug discovery, pharmacovigilance and healthcare analytics.

IP

Intellectual Property Rights

Patent law, IP strategy and regulatory exclusivity across the product lifecycle.

AM

Analytical Method Validation

From theory to practice: ICH Q2(R2), HPLC hands-on, system suitability and reporting.

MD

Molecular Docking & Network Pharmacology

Target prediction, docking, ADMET and network analysis for research projects.

PY

Python for Pharma Scientists

Data handling, statistics and automation for lab, QC and research data.

Publications & IP

We write the books we teach from.

Our authoring and patent work is the same expertise we offer clients who want to publish a book, a paper or protect an invention.

Cover of Quality by Design (QbD) in the Pharmaceutical Industry

Quality by Design (QbD) in the Pharmaceutical Industry

Sujith Nair · Kripa-Drishti Publications · ISBN 978-81-991218-6-7

A practitioner's guide to applying QbD principles to method development, validation and product development.

Cover of Artificial Intelligence in Drug Discovery and Development

Artificial Intelligence in Drug Discovery and Development

Taratey, Nair, Shinde, Kulkarni, Shaikh · Lulu Publishing · ISBN 978-0-557-94262-6

How machine learning and data science are changing target discovery, screening and development.

3 patentsFiled by our team, from idea to specification
Honorary membershipAll-India Consortium of Pharmaceutical Training (AICPT)
Research & publicationsPeer-reviewed papers, book chapters and conference work
Key moments

On campuses, in labs and at industry events.

How we work

A transparent engagement, from first call to sustained compliance.

Step 1

Discover

An introductory call and NDA to understand your product, market and challenge.

Step 2

Assess

We review your data, documents and systems to define the gap and the risk.

Step 3

Propose

Scope, deliverables, timeline and commercials agreed up front.

Step 4

Execute

Experienced experts deliver, with milestone reviews and regular updates.

Step 5

Deliver & sustain

Final documents, knowledge transfer, training and post-delivery support.

Project-based

Fixed scope, deliverables and timeline.

e.g. a method validation or a dossier

Retainer

A dedicated expert embedded with your QA, QC, R&D or regulatory team.

e.g. monthly QA support

On-demand

Rapid help when a deadline or an inspection is close.

e.g. a deficiency letter or OOS

Training & audits

Upskilling and mock-audit programmes on-site or online.

e.g. pre-inspection readiness
People

Industry experts and academic advisors.

SN

Mr. Sujith Nair

Director & Co-Founder, Spectratix Pharma Pvt. Ltd. Specialist in analytical method development and validation and the QbD approach, author of Quality by Design (QbD) in the Pharmaceutical Industry, and honorary member of AICPT.

BT

Mr. Bhushan Tarwate

Co-Founder & Director · Business Development

AJ

Mr. Aniket Joshi

Director · Finance & Corporate Affairs

SW

Mr. Sandeep Wakchaure

Director · Research, Innovation & Academics

UP

Dr. Upendra Pendse

Analytical expert · Industrial advisor

SP

Dr. Satish Polshettiwar

AI expert · Academic advisor

SB

Dr. Shashikant Bhandari

Formulation expert · Academic advisor

TM

Dr. Teena Merlin

Analytical research specialist · Scientific advisor

SR

Dr. Sushil Raut

Medical writing expert · Industrial advisor

RM

Dr. Rajesh Mali

Consultant · Audits & Regulatory Compliance

IO

Ms. Isha Ostwal

Growth partner

Questions

Frequently asked.

Do you work with international clients?

Yes. We support clients across India and overseas, with remote delivery for documentation, regulatory and data work and on-site support across India. Markets we prepare submissions for include the USA, EU, UK, Brazil, WHO-PQ, ASEAN, GCC, LATAM and Africa.

Will you sign an NDA before we share details?

Always. Every engagement starts with an NDA, and we agree on who owns each deliverable before work begins.

Which regulatory agencies do you have audit experience with?

USFDA, EU GMP authorities, MHRA, ANVISA, WHO and CDSCO, along with customer, ISO and accreditation audits.

Can you help with PhD research or publishing a paper?

Yes: research design, data analysis, network pharmacology, docking, manuscript preparation, journal selection and responses to reviewers. All support follows publication ethics: authorship stays with the people who did the work, and writing assistance is disclosed where journals require it.

Do you work outside pharmaceuticals?

Yes. We support biotech, medical devices, semiconductors, and food, water, environmental and soil testing, wherever validated methods, data integrity and regulatory compliance matter.

How can a college or university partner with you?

Through an MoU covering guest lectures, certificate programmes, hands-on workshops, faculty development, internships and research collaboration. These activities also support accreditation documentation.

We have an urgent deficiency letter or inspection. Can you help quickly?

Our on-demand model is built for that. Share the letter or audit date and we will confirm scope and turnaround on the first call.

Contact

Tell us what you are working on.

Share your requirement and we will respond with a tailored proposal, scope and timeline.

Phone+91 95791 59287
Emailcontact.spectratixpharma@gmail.com
OfficeA-801, Urban Forest CHS, Near Masulkar Farms, Mamurdi, Pune 412101, India
HoursMonday to Friday, 9 am to 6 pm IST