Regulatory Affairs Solutions for Utmost Compliance

Navigating the intricacies of regulatory requirements is paramount. Our comprehensive suite of services ensures a smooth journey for the pre-evaluation, registration, and ongoing compliance of medicines, medical devices, food supplements, and cosmetics in national competent authorities across the Baltics and other EU countries.

Contact us now for a FREE quote!

Enhance the process for pre-evaluation, registration, and continuous compliance of medicines, medical devices, food supplements, and cosmetics with national competent authorities across the Baltics and other EU countries. Complete the form on the right and take the initial step toward a smoother journey.

Our Services

Marketing Authorization for Medicinal Products

Navigate the complex landscape of regulatory approvals for both human and veterinary medicinal products. We specialize in obtaining marketing authorizations, ensuring your products meet the most standards set by regulatory authorities.

Notification of Food Supplements and Food for Medical Purposes

Efficiently navigate the regulatory landscape and notify food supplements and food for special medical purposes. Our expert guidance ensures compliance with all notification requirements.

Processing of Adverse Drug Reactions (ADRs)

Handle adverse drug reactions with our specialized service. We manage the processing of ADRs, ensuring compliance and timely reporting to regulatory authorities.

Annual and Safety Updates for Medicinal Products

Stay ahead with our expert assistance in handling annual updates and safety updates for medicinal products in the European Medicines Agency (EMA). We ensure your products comply with evolving regulatory standards and safety requirements.

Cosmetic Product Notification (CPNP)

Ensure your cosmetic products meet regulatory standards through our streamlined notification process in the Cosmetic Products Notification Portal (CPNP). We assist you in the notification of cosmetic products for a hassle-free compliance experience.

Medical Device Notification

Streamline the notification process for medical devices with our specialized service. We handle the intricacies of registration in national competent authorities, ensuring compliance with the latest regulations.

Medical Writings (PSURs, RMPs)

Trust our experts for precise and comprehensive medical writings, including Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).

Why Us

Because We Care

We care about your business, about your prospects, about the environment, about our employees.

Expertise at the Forefront

We take pride in our top-notch expertise in regulatory affairs, market access and reimbursement services.

Enhanced Client Satisfaction

Satisfaction of clients is our core value as we constantly grow our pool of knowledge to win the competitive edge of our customers.

Customer Testimonials

  • “We have been cooperating with this company for more than a year: both in the drug registration processes and in further actions related to the appearance of the medicinal product on the market. Believe me, they know everything and do it professionally and qualitatively.”

    — Laura Sabulyte, JSC Recipe Plus

  • “We are cooperating with Carolpharma around 2 years, regarding requests in the field of regulatory. The service is smooth and straightforward. My advisor is always helpful. Great customer support from beginning to end of the process. Definitely recommend this fantastic organisation.”

    — Dmitrijus Raskatovas, Ltd. Vitaflo International

  • “We are very grateful for our reliable cooperation with Carolpharma, which has proven to be sustainable for many years.”

    — Ludmila Bogataja, Ltd. Magnum Medical

  • "I have a long cooperation history with Carolpharma- always positive, responsive and assisted in multiple projects concerning notification of medical devices and food supplements."

    Marina Dukate, Ltd. Austrumu medicīna

  • ''We have been cooperating with Carolpharma for food supplement registration. The high-performing team always quickly and professionally provide the necessary consultations, ensure the preparation of documents and answer all questions. Altogether providing excellent service.''

    Viktorija Vlasenko, Ltd. Adore Digital

Meet Our Team

  • MBA Karlina Jurjeva

    CEO

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  • Mg.pharm. MBA Gerda Putnina

    Pharmaceutical Projects Manager

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  • Mg.pharm. Marta Silavniece

    Market Access Lead

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Reach out to us today