Suven Pharma provides powerful formulation development services to support the development of chemistry for your pipelines without having experience in manufacturing. Our expert team develop stable and compliant formulations for right API and the best dosage forms.
Formulation Development and Analytical services
of our formulation development services:
NCEs Formulation Development
Suven Pharma solves early-stage formulation challenges for NCE product candidates in Phase I or Phase II and accelerate the go to market with powerful formulation solutions and pipeline possibilities. Our manufacturing capabilities for NCEs includes Real-time formulation development support for adaptive clinical trials and reduced production costs with novel dosage forms that minimize R&D iteration. At Suven Pharma we focus on making the chemistry stable , safe, and developing effective dosage form for patient administration in the drug development process.
Offered by Suven Pharma includes :
The team conducts pre-formulation studies to determine the physicochemical properties of the drug substance, including solubility, stability, and compatibility with excipients.
We develop formulations for a wide range of dosage forms, including solid orals , liquid orals, topical liquids, semi-solids, injections, sachets and Nano Tech Products. Suven pharma can help optimizing the formulation to enhance drug delivery, bioavailability, and stability.
Analytical method development
We develop and validate analytical methods to measure the drug substance and product's quality attributes and ensure regulatory compliance.
We develop and optimize the manufacturing process to ensure consistent product quality, minimize manufacturing costs, and improve efficiency.
Scale-up and technology transfer
We help our partners to scale-up the manufacturing process from lab to pilot scale and transfer the technology to commercial-scale manufacturing.
With our 33 + years’ experience of working with innovators and regulate market partners, we offer regulatory support and guidance ensuring compliance with the regulatory requirements of various regulatory agencies including US FDA and EMA.
Drug products to market
Suven Pharma analytical services includes the usage of analytical methods to evaluate the quality, safety, and efficacy of chemistry of drug throughout the development and manufacturing process of the products.
Our broad range of analytical services enables our partners to launch high-quality drug products.
Overall, analytical services are critical to ensuring the quality, safety, and efficacy of drug products. CDMOs offer a broad range of analytical services, enabling pharmaceutical and biotechnology companies to bring high-quality drug products to commercialization.
Microbiology Laboratory Instruments
Quality, Safety, and Efficacy of Drug Products
Method development and validation:
We develop and validate analytical methods include chromatography, spectroscopy, mass spectrometry, and other techniques to measure the quality attributes of drug substances and products.
Stability testing to evaluate the shelf-life of drug products under various storage conditions.
Impurity analysis identify and quantify impurities and degradation products in drug substances and products using analytical methods.
Release testing to ensure that drug products meet the required quality standards before they are released for distribution.
Microbiological testing to ensure that drug products are free from microbial contamination and meet the required standards.
Analytical method transfer:
We help transferring analytical methods from one laboratory to another, ensuring consistency in the results obtained.