Regulatory consulting services

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...

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. 

Learn more about SHL...

Our Chemistry, Manufacturing and Controls (CMC) specialists help customers manage the product’s compliance at every step, from clinical development to market authorization. With decades of experience, our experts provide support in navigating regulatory milestones, including site registration, product ...

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...

Regulatory Service Provider

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...

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 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 ...

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 ...

License holding service for Drug in SEA

Import Handling and Distribution service in SEA countries

Zenovel has a highly experienced team of experts who have a complete understanding of the complete requirements of Pharma Regulatory affairs throughout the drug life cycle. Our experts have experience in directly corresponding with Pharma regulatory authorities for various segments.
...

Atop pharma solutions is a global leader in regulatory, pharmacovigilance, legal and translation services. We support pharmaceutical companies to meet their regulatory requirements in all the key markets like Europe, North America, Asia, Africa and Latin America. We believe in helping pharmaceutical c...

Emtex offers worldwide professional medical writing and related services to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions.

We offer various GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:

1) Knowledge: Various regulatory requi...

We offer various GMP services which can help the clients across globe, ranging from audits to various consulting services.

We provide following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

• Audits 

• API Audit Reports 

• QMS/Complia...