Regulatory consulting services

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.

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’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 Medical...

The compliance environment of the pharmaceutical and life science industry can offer very complex challenges. One issue is optimizing workplace technologies in the areas of Business Process Changes, Validation, and general GxP Compliance. At the same time, these challenges must be balanced with the develop...

CMC involves defining manufacturing practices and product specifications that must be followed and met to ensure product purity and consistency between batches. CMC begins after a lead compound is identified through drug discovery and continues through all remaining stages of the drug development lifecycle...

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...

To achieve your goals in a regulatory authority meeting, the interaction must be carefully planned and flawlessly executed, leaving the regulatory agency with a good impression of your product and company. This requires expert guidance from professionals who have prior regulatory experience and know the ap...

Expert guidance and regulatory submission support throughout the entire development and launch processes. With over 35 years of experience, we will plan and coordinate every detail of a clear and complete US/European submission. We’ll utilize our extensive regulatory and scientific experience engaging with...

Services supporting successful outcomes provided end-to-end

We help clients achieve positive regulatory outcomes using a scientific approach as the driver of success.
As the world’s leading provider of regulatory consulting services, we support our ...

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 ...

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.
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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 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...

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...