Research & Development

Research & development

WHO WE ARE

SPIMACO’s R&D Department plays a pivotal role in driving innovation and excellence in the pharmaceutical industry. It is dedicated to developing new, high-quality pharmaceutical products and enhancing existing formulations to meet evolving healthcare needs.

Developing new generic products and prepares registration files, boosting the company's portfolio and asset value.

Developing patented non-infringing formulations and conducts clinical bioequivalence studies for SFDA dossier registration.

Evaluating and localizing technology transfer products by completing technology batches, stability studies, and filing with the SFDA.

Providing technology transfer, technical support for products, and assistance to the company's affiliates.

Developing Tomorrow's Medicine

We develop new medicines through thorough research and the sourcing of high-quality ingredients. By optimizing formulations and ensuring stringent quality standards, we deliver safe and effective therapies that enhance patient care.

Step:1

Reading literature & gathering technical information on the product to be developed.

Step: 2

Sourcing suitable suppliers for the drug substance & excipients with asking for the appropriate documentations.

step: 3

Ordering the Reference products (Originator) & do full physicochemical characterization.

step: 4

Establishing the product quality target profile (QTPP), Critical quality attributes (CQA) & Critical process parameters (CPP)

step: 5

Establishing a development plan

step: 6

Establishing a development plan

step: 7

Establish product specification & analytical procedures and its validations.

step: 8

Formula and process optimization

step: 9

Manufacture stability batches & put in stability chambers

step: 10

Conduct Bioequivalence study

step: 11

Compile the technical files & submit to Regulatory Affairs

R&D Driving the Future

We are driving the development of advanced therapies to address global health cardiovascular and infectives-anti as such areas on focusing. By health, it plays a key role in shaping the future of healthcare.

Anti Infectives

Cardiovascular System

Alimentary / Metabolism

Systemic Hormones

G.U. System & Sex Hormones

Musculoskeletal System

Antineoplast + Immunomodulators

Nervous System

R&D Role in Product Registration

We address technical inquiries, conduct stability studies throughout the product’s shelf life, and oversee process validation for initial commercial batches to ensure that high-quality standards are met.

STEP:1

Responding to technical inquiries received from evaluation committees at the Saudi Food and Drug Authority and export markets

STEP:2

Completing stability studies until the end of the shelf life for all new products

STEP:3

Upon product registration, overseeing the process validation monitoring for the first three commercial batches