The combination of drugs products is using
therapies. We provide combinations or co-packaged drugs to meet your customer
needs. However, the combination
drugs development of drug evaluation of two or more molecules. We
consider complementary effects to interest in the better development of
formulation products. There are possible to co-formulation of development as
well as it defined to products are drug components with a single dosage. In the
main factor, these products reduce the number of improvement with leads to the
extension of products. On another hand, we offer the food and biologic
combination with two or more marketed drug products. Mainly focus one appears
to safe approaches as well as access the historical data and knowledge of
stability-indicating assays for each molecule
Manufacturing drugs:
Most
importantly, we offer the fixed point of the combination that will present the
modified manufacturing technique. It is a very testing basis as well as more
methods of access to bother constituent parts as well as a combination of
products. There are possible for appropriate products are manufacturing
consider these as early prepare post-approval change further discussion with
FDA. Of course, the develop the combination of products are covered and
manufactured the good manufacturing practice with a single entity and
co-packaged combination products
- Full Compliance Approach
- Streamlined Approach
Our professional team developed the drugs
and high recommendations and advice and regulatory issues that may arise during
development. Mainly focus on the investigation of the drug to use the
combination of guidance with relevant approved drugs. Now, we proposed with
generated to related drug products with engaged the lots of efforts and more
combinations of products. Now, we manage the Streamlined Approach are choose to
their product to lead some responsible with preapproval inspections regardless
of the pathway chosen. There are possible to the primary mode of demonstrating
with full of approaches still requires wit particular set of processes. There
are possible to safe and secure the proper combination product has superiority
compared to monotherapy. For instance, we are also challenged with a molecule
of issues of formulating higher concentration with certain protein and particle
formulation.
- Strategy development
- CMC
- Toxicology
- Pharmacokinetics
- Clinical efficacy
- Clinical safety
- Labeling
- FDA grants of exclusivity
- Patent submissions & grants
- NDA line extensions
- Published clinical literature
- Nonprescription products
Regulatory Consulting Services:
The
regulatory experts are customized that regulatory support ranges widely in
medical device classification. Our professional team experts help to important
stay one step ahead of regulatory changes as well as optimize their end-to-end
regulatory activities. The regulatory
consulting approaches to resolve the high products to recall form
different consultants to a deep understanding with interact due to the sense of
important things to empower you to maintain control compliance risks. It is very safe and secures the consulting
management of valued product services with original information to help our
clients to reduce risk. Moreover, you can understand the guidance of apply and
working process. We offer the support and services for any Pharmaceutical
market. Then, we maintain some experts to allow lots of approaches to comply
with regulations.
Regulatory
Support In Multiple Ways:
- Common Assignments
- Regulatory assessment
- Global regulatory strategy development
- FDA advisory panel preparation
- Creation of technical files
- Recall planning and management
- Inspection advise and management
- Quality Systems training
- Perform due diligence assessments
- Audit preparation
- Acting as Designated Agent
- Technical papers and abstracts
- Literature searches and bibliographies
- Writing and developing SOPs
- Annual progress reports
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