Our Services
Comprehensive pharmaceutical regulatory and manufacturing services for global market success
Complete Solutions
From regulatory compliance to manufacturing excellence, we provide end-to-end pharmaceutical services
Analytical Testing
Start-to-finish cGMP analytical services across a network of labs for product viability.
Discovery & Development
Integrated approaches from design and optimization to commercial scale manufacturing.
CDMO & CMO Services
Focused on NCE, RSM, and intermediates from lab scale to commercial manufacturing.
Analytical Testing Services
Operant’s extensive start-to-finish cGMP analytical services ensure your compound and product attributes, while our high-end analytics labs provide key data and insights needed to keep your product on-track. We maintain a complete suite of chemistry-based analytical services and method development for both biologics and small molecule therapeutics.
- HPLC/GC stability indicating methods
- Residual solvent and cleaning methods
- Enantiomeric purity (Chiral HPLC)
- PGI by GC-MS and HPLC-MS
- Nitrosamines & Ion-Chromatography
- Particle size methods
- Structural ID by MS and NMR
Method Development & Validation
We offer a phase-appropriate approach to ensure that the correct level of development and validation is applied depending on the phase of development. Validations are performed in compliance with ICH and USP guidelines.
- Liquid/Solid state methods
- Development life cycle support
- Highly skilled scientist team
Small Molecule Discovery & Development
We offer a wide array of integrated services—from design and optimization, to manufacturing, to analytical support. We help develop alternate Routes of Synthesis (ROS) along the journey from brainstorming to conducting techno-commercial evaluations.
- Synthetic Route Scouting and Design
- Process Development (DOE & QbD)
- Salt Screening & Polymorph studies
- Impurity Profiling
- Custom Synthesis (kg to multi-kg)
Strategic R&D Solutions
Supporting your program across the entire Drug Development Continuum, from brainstorming to established proof-of-concept and ensuring process sustainability.
Technology Transfer
Smooth scale-up of chemical processes with full-fledged process safety evaluations. Our team of process engineers works alongside development chemists to evaluate and prepare processes for scale-up.
- Process safety evaluations
- Detailed checklists and SOPs
- 24-hour coverage for first campaigns
- Site technical absorption
How It Works
Selection starts with scalability insight. Early-phase focus is speed and safety; later phases build robustness. Tech packages include chemistry, analytical, and HSE sections. A pre-startup review captures and mitigates all risks.
Why Choose Operant?
- Engineers working with chemists during dev
- Tech absorption engineers at site for retrofitting
- Mimic plant conditions at R&D scale-up facility
CDMO & CMO Services
A leading CDMO in India for drug substance (NCE, RSM, Intermediates) projects. We act as an extension to our client's laboratories, helping bring molecules to market faster.
- Ph-I/II/III Clinical supplies
- NCE drug development programs
- Dedicated scientific and project teams
- Intermediates and RSM manufacturing
Engagement Process
Engagement begins by identifying multiple concepts based on literature and think-tank sessions. Concepts are evaluated for chemistry challenges, cost, supply assurance, operational feasibility, HSE, and IP status.
CMO Excellence
Leveraging decades of scientific expertise and best-in-class facilities for supply chain assurance. We help with time-to-market planning and regulatory compliance.
Route Scouting (Deep Dive)
Establishing innovative Route of Synthesis (ROS) from an idea to a sustainable process. We prioritized Proof of Concept (POC) work with well-documented pros and cons.
- Alternate ROS development
- Techno-commercial evaluation
- Proof-of-Concept establishment
- Sustainability ensuring
POC Program
Fast-tracked, time-bound programs using parallel synthesizers (PolyBLOCK) with independent temperature-controlled blocks.
- Potential chemistry challenges assessment
- Cost and assurance of supply
- IP and HSE assessment
Manufacturing Capabilities
World-class facilities offering global-scale commercial production at cost-effective pricing. Handling complex chemistries with first-time quality.
- 1KG scale to 500 MT per year
- Stainless steel, Glass lined, Hastelloy reactors
- Continuous hydrogenation facilities
- Flow Chemistry (Lab to Mfg)
- Cryogenic reactions (-100°C)
- High potency (OEL: 1-10 µg/m3)
- Sterile block for Oncology APIs
Research & Development
Establishing ourselves as a global pharma API and intermediates manufacturer. We embrace open innovation and sustainable nutraceuticals.
- Route Scouting and Design
- New Product Development
- Process Optimization & Scale-up
- Life Cycle Technology Management
Chemistry Expertise (Plant Scale)
- Ammonolysis
- Chlorination
- Fluorination (Halex)
- Hydrogenation
- Nitration
- Sulphonation
Chemistry Expertise (Lab Scale)
- Asymmetric Hydrogenation
- Biocatalysis
- Chiral Chemistry (Enzymatic)
- Flow reactor technology
- Organometallic Coupling (Suzuki, Negishi)
- Cryogenic Reactions
- Steroid Chemistry
Operant Publications
A Division of Operant Scientific empowering researchers with advanced publishing solutions, peer-reviewed journals, and global visibility.
- Trusted Peer Review (median < 2 months)
- 5+ High-impact Journals
- Gold Open Access options
- Chemical & Engineering News magazine
Our Mission
To provide high-quality information products that advance the practice of chemical and related sciences for the benefit of Earth and its people.
Diversified Products
High-quality industrial and consumer products extending our manufacturing excellence into new markets.
- Industrial Acrylic Pipes
- Decorative Bangles & Accessories
- Custom Acrylic Solutions
- Fashion Accessories
Success Story
How we helped a pharmaceutical company achieve global market entry
Global Generic Drug Launch
We partnered with a European pharmaceutical company to launch their generic cardiovascular medication in 15 countries across Asia and LATAM. Our comprehensive regulatory and manufacturing support enabled rapid market entry with full compliance.
Services Provided
- CTD/eCTD preparation for all markets
- Bioequivalence study coordination
- Manufacturing and supply chain setup
- Local regulatory liaison
Ready to Get Started?
Contact us today to discuss how our services can help your pharmaceutical business succeed globally.