Regulatory consulting services

From early-stage development to post-approval, we partner with pharmaceutical, biotechnology, and medical device clients to overcome regulatory hurdles. Using science as the driver for success, we help our clients achieve positive regulatory outcomes with the Food and Drug Administration (FDA), Europea...

SHL Medical’s commitment to innovation has driven our leadership in the drug delivery industry. We offer vertically integrated expertise and capabilities to ensure the production of our self-injection systems are delivered with unparalleled speed, quality, and reliability. 

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Our team of experts will prepare necessary protocols incorporating all critical parameters


Process Validation:

PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...

Synerlab provides wide range of services which includes development. Contact us for more information.

Aptar Pharma's specialized analytical, development and regulatory services contribute value throughout the entire drug development process, expediting progress and mitigating risks along the journey.

Ensure your products meet all regulatory standards with our comprehensive Regulatory Affairs service. At YallaRx, we provide expert guidance and support to navigate the complex landscape of regulatory compliance.Our service includes:Product classificationAt the client's request or in case of doubt that it ...

Our expertise offered in regulatory submissions and knowledgeable strategic skills in planning non-clinical testing programmes can reduce attrition rate and speed up the process.

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...

Company and products registration in Saudi Arabia (Saudi Food and Drug Authority - SFDA).

We provide solutions to meet both local and global regulatory requirements in the most cost-effective manner.

PharmEng supports Pharmaceuticals, Biologics, Over-The-Counter (OTC), Animal Health, Radiopharmaceuticals, Clinical Trial Products, Medical Devices, Combination Products, Natur...

We provide solutions and technologies that reduce human intervention and increase efficiency.

Automation is offered in DCS projects independent of the automation vendor. We offer professional services in implementing Automation process control and maintenance in accordance with industry standards ...

Our Subject Matter Experts provide training that fulfill all regulatory requirements

Training is an integral part of GMPs. The operations involved in the manufacture of regulated products are highly technical in nature. Inadequate training of personnel can result in products failing to meet the ...

Our experts ensure clients' safety by protecting them from pharmaceutical hazards

At PharmEng Technology, we understand the importance of evaluating the toxicity and safety of biopharmaceuticals, therapeutic proteins, chemicals, active pharmaceutical ingredients, and components.

P...

We protect the integrity and quality of your temperature sensitive pharmaceutical products to meet all regulatory requirements

PharmEng Technology has developed standards and methods to perform thermal process ratings according to your specifications. Our professionals are equipped with the righ...

We establish and manage quality systems specifically tailored to clients’ operational needs.

Our clients understand the importance of establishing a robust quality system; The effort in maintaining a strong quality system not only ensures that the products and services meet the customer expectat...

Our experts incorporate the most modern and efficient Project Management techniques to ensure all project goals and objectives are met

PharmEng Technology has recognized that Project Management is essential throughout the Pharmaceutical, Biotechnology, and Medical Device industries.
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We help bring concept ideas to life

PharmEng engineers are experienced in building scalable and robust pharmaceutical production facilities and processes while employing state of the art techniques to meet and exceed operational and regulatory requirements.

Our experts have succes...

Our qualified consultants strive to exceed your project goals and objectives

Our flexibility and project experiences range from the qualification of an individual piece of equipment to an entire facility.
Our PharmEng professionals have extensive experience in the development, imple...

Regulatory Service Provider

License holding service for Drug in SEA