Regulatory consulting services

Regulatory consulting services Companies (11)

Regulatory consulting services News

Regulatory consulting services Products (16)

  • Product Biologic drug substance CDMO 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...
  • Product Autoinjector development expertise and capabilities

    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...
  • Product Regulatory Support

    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 ...
  • Product Validation

    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...
  • Product Drug Registration

    Regulatory Service Provider
  • Product Commissioning & Qualification

    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...
  • Product Engineering

    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...
  • Product Training

    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 ...
  • Product Automation Engineering Solutions

    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 ...
  • Product License Holding Service

    License holding service for Drug in SEA
  • Product Import Handling and Distribution

    Import Handling and Distribution service in SEA countries
  • Product Regulatory Support

    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.
    ...
  • Product Trademark, copyrights, Regulatory affairs, PV, Translation

    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...
  • Product Medical Writing

    Emtex offers worldwide professional medical writing and related services to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions.
  • Product GCP Services(Good Clinical Practices)

    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...
  • Product GMP Services(Good Manufacturing Practices)

    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...

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