As a pharmaceutical company, you know that developing and manufacturing high-quality drug
products is a complex
process that requires expertise and resources. That's where Contract Development and
Manufacturing Organizations
(CDMOs) come in. CDMOs offer a wide range of services, including process development,
analytical testing,
formulation, and manufacturing of drug products for pharmaceutical companies.
At Clearsynth, we understand the importance of quality, reliability, and flexibility when it
comes to CDMO services.
That's why we offer a comprehensive range of CDMO services to meet the needs of our clients,
from small biotech startups
to large pharmaceutical companies.
Process Development: Our team of experts can help you optimize
your process to ensure the best possible results. We use cutting-edge
technologies and advanced analytics to develop a robust and scalable process.
Analytical Testing: We offer a wide range of analytical testing services,
including method development, validation, and stability testing. Our
state-of-the-art equipment and experienced analysts ensure accurate and reliable
results.
Formulation: Our experienced scientists can help you develop
and optimize the formulation of your drug product. We use advanced tools and
technologies to ensure optimal solubility, stability, and bioavailability.
Manufacturing: We offer GMP-compliant manufacturing services for
both clinical and commercial products. Our facilities are equipped with the
latest technology and operated by experienced professionals who ensure that your
products are manufactured to the highest quality standards.
We understand that every client's needs are unique, and we offer customized
solutions to meet those needs. We pride ourselves on our flexibility and
responsiveness, and we work closely with our clients to ensure their success.
Good Manufacturing Practices (GMP) are a set of guidelines and regulations that ensure the quality, safety, and efficacy of drug products. Compliance with GMP regulations is essential for pharmaceutical companies to obtain regulatory approval for their products.
At our company, we understand the importance of GMP compliance in the pharmaceutical industry. That's why we offer a comprehensive range of GMP services to ensure that our clients' products meet all regulatory requirements.
Route Scouting: Identifying the most efficient synthetic pathway for a
specific target molecule
Process Design and Optimization: Designing and optimizing the manufacturing process for the
target molecule
Standardization of Synthetic Steps: Developing a standardized process for synthetic steps
that can be scaled up for commercial manufacturing
Synthetic Demonstration: Performing a proof-of-concept synthesis for a
target molecule
Scale-Up Manufacturing: Scaling up the manufacturing process for a target molecule to
produce larger quantities
Analytical Method Development: Developing and validating analytical methods
to ensure the quality and stability of the target molecule
Salt Screening and Polymorph Studies: Investigating the effects of
different salts and polymorphs on the properties of the target molecule
Technology Transfer: Transferring the optimized process technology for
manufacturing the target molecule to a pilot plant for further testing and production.
At Clearsynth, we are committed to providing high-quality CDMO services to our clients in
the pharmaceutical industry.We have received several quality accreditations that demonstrate
our commitment to excellence and our ability to meet
regulatory requirements.
ISO 45001:2018: This standard sets requirements for occupational health
and safety
management systems. Our compliance with this standard ensures that we provide a safe and
healthy working environment for our employees and visitors.
ISO 9001:2015: This standard sets requirements for quality management
systems. Our
compliance with this standard ensures that we consistently provide products and services
that meet customer and regulatory requirements.
ISO 14001:2015: This standard sets requirements for environmental
management systems.
Our compliance with this standard ensures that we minimize our environmental impact and
comply with relevant environmental regulations.
ISO 17034:2016: This standard sets requirements for the competence and
consistent
operation of reference material producers. Our compliance with this standard ensures
that our reference materials are of high quality and are suitable for their intended
use.
ISO/IEC 17025:2017: This standard sets requirements for the competence of
testing and
calibration laboratories. Our compliance with this standard ensures that we provide
accurate and reliable test results to our clients.
US FDA Registration: Our registration with the US Food and Drug
Administration (FDA)
demonstrates our compliance with US regulatory requirements and our ability to
manufacture drug products that meet FDA standards.
DSIR Recognition: Our recognition by the Department of Scientific and
Industrial
Research (DSIR) in India demonstrates our commitment to research and development and our
ability to innovate in the pharmaceutical industry.
We take quality seriously and are committed to continuously improving our processes
and services to meet the needs of our clients. Contact us to learn more about our quality
accreditations and how we can help you with your CDMO needs.
We understand that every client's needs are unique, and we offer customized solutions to
meet those needs. We pride ourselves on our flexibility and responsiveness, and we work
closely with our clients to ensure their success.
If you're looking for a reliable partner for your CDMO services, look no further than our
company. Contact us today to learn more about how we can help you bring your drug product to
market.