International Market

• Providing readily access to multiple markets and expertise

• Strong global network of drug technology and manufacturing

• Quality and Regulatory capability to meet the demands of different markets

Regulatory Affairs

We provide comprehensive Regulatory services across the spectrum of product development, registration and commercialization. We deliver informed advice and pragmatic services and solutions for new product and market authorizations, Health Authority submissions, post approvals, CMC and lifecycle management to help companies maximize their product’s commercial potential and market success.

We provide the following regulatory services:

• Modules preparations including report writing for module 2.7 and 3.2.P

• Publishing and Submission Regulatory Labeling 

• Artwork Services 

• Safety and Pharmacovigilance

• Clinical study design, audit and monitoring 

Contract Manufacturing

Pharmaceutical companies, rely on contract manufacturers to meet their manufacturing and testing needs. To maintain the high-quality product standard, the contractor’s facility should be Good Manufacturing Practice (GMP) certified (PICs approval, Local GMP, etc.). Contract manufacturers register their products across the globe depending upon their client’s requirements. As such, contract manufacturers should be aware of global requirements, should strictly follow manufacturing guidelines and should ensure that the facility is audit-ready for the health authorities (HAs) they’re dealing with.

Elite can find you the best contract service to fix your needs and ensure they maintain a high level of cGMP.

Product Development

Pre-formulation

Our laboratory is capable of conducting physicochemical characterization of new and existing drug molecules and finished dosage forms to guide development of complex dosage forms.

Formulation Development

Our formulation development provides a full range of pharmaceutical dosage forms—from conventional to specialized drug delivery systems. Our lab is fully Equipped with conventional and modernized equipment which put us in a uniquely advantage to be cost-effective and robust manufacturing process.

Analytical

Our analytical lab is equipped with top-of-the-line instrumentation, as well as experienced scientists, our analytical services includes early state product characterization, analytical method development/validation, and stability program.

cGMP & Compliance

We provide the following cGMP & compliance services, preferably through product collaboration: 

• Manufacturing facility design cGMP concept review

• Manufacturing equipment selection & qualification

• QC laboratory, including quality control system set-up, testing instrument selection & qualification

• Quality assurance system set-up 

• Process validation program design & execution