Regulatory consulting services

Regulatory consulting services Companies (13)

Regulatory consulting services News

Regulatory consulting services Products (25)

  • Product Regulatory Sciences

    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...
  • 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 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 Development

    Synerlab provides wide range of services which includes development. Contact us for more information.
  • Product Registration of dietary supplements, medicines, cosmetics

    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 ...
  • Product Consultancy for drug/MD/food development

    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.

  • 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 SFDA Registration - Saudi Arabia

    Company and products registration in Saudi Arabia (Saudi Food and Drug Authority - SFDA).
  • Product Regulatory Affairs

    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...
  • 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 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 Toxicology

    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...
  • Product Thermal Mapping

    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...
  • Product Quality Systems

    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...
  • Product Project Management

    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.
    ...
  • 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 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 Drug Registration

    Regulatory Service Provider
  • Product License Holding Service

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

    Import Handling and Distribution service in SEA countries

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