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CTD Conversion

In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African Common Technical Document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.

From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).

Freyr is currently working with many Global Pharmaceutical and Consumer Health Care companies in supporting them in planning and executing the CTD conversion requirement for the existing and new product registrations in South Africa enabling them to meet the MCC mandate.  For some of these global companies CTD conversion is a time consuming and a huge responsibility that needs careful planning and execution given their growing product portfolio in the African market.

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Good Manufacturing Practice

Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards.

  • Regular periodic or rolling quality reviews of all registered medicinal products, including export only products are conducted.
  • The Manufacturer and Holder of Certificate of Registration, where different, should evaluate the results of the review and an assessment should be made of whether corrective and preventative action or any revalidation should be undertaken.

Medicines Control Council’s (MCC)  general policy is that the standard to be used to assess compliance with current Good Manufacturing Practice (cGMP), is the South African Guide to Good Manufacturing Practice (SA guide to GMP).

  • Under Section 22C of the Act, all South African manufacturers should be licensed
  • The Act requires that overseas manufacturers of medicine supplied to South Africa should comply with the same or equivalent manufacturing standards as expected of South African manufacturers
  • When acceptable evidence of GMP compliance is not available, overseas manufacturers are inspected by the GMP Inspectorate before registration of the medicine is approved

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Medicines Registration

Medicines to be used in South Africa for both public and private sectors shall be duly registered with the national regulatory authority, the Medicines Control Council’s (MCC) in accordance with the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965 and the Regulations and Guidelines published in terms thereof.

A written notification from the Minister to the effect that the medicine is considered essential to national health; an expert report (which is not more than 2 (two) years old; a package insert (where the product has been approved) and a summary basis for the registration (SBRA) should be submitted with application.

The Registrar shall notify the applicant within 30 days of the date of receipt of the application and the Council shall, within 9 months make a decision with regard to the application.

The abbreviated medicine review process is based mainly on the expert reports of the pharmaco toxicological and clinical data.

Applications for Abbreviated Medicine Review Process (AMRP) can only be accepted if the product has been approved by the said authorities within the last three years of the license in the licensing country.

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Submissions Publishing

In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African common technical document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.  From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).

With the need for converting old format submissions to CTD format comes the opportunity for Market Authorization Holders (MAH) to plan and be ready for electronic submissions.  Freyr can compile submissions in eCTD format and print in paper format as required by the current MCC requirement. This allows the MAHs to be prepared for future eCTD requirements from MCC and enables efficient electronic submission dossier management.

Registrations and Submissions Information Management

Module 1 (Administrative 1.10 Foreign Regulatory Status) requirement from Medicines Control Council’s (MCC) requires the applicant to provide a list of countries in which an application for the same product is being applied for in South Africa has been submitted, dates of submission (if available). This should detail approvals (with indications).  Applicants must declare whether a marketing application for the medicine has been rejected in the countries listed under 1.10.1 prior to submission of the application in South Africa. If the medicine has been rejected, repeatedly deferred or withdrawn, then the MCC must be informed and the reasons supplied.

If no application has been submitted for registration in the country of origin, include a statement to provide the reason for this decision. It should be noted that aforementioned information is required to be provided in dossier however, it does not mean that this will help to speed up the review process.

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      Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

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Press Releases

  • Freyr Surpasses the 100+ Clients Milestone

    June 2017

    28, June 2017, New Jersey – Freyr is excited to announce that the organization has surpassed the 100+ clients milestone. Achieving it in just a handful of years since the inception, Freyr as an organization feels grateful to avail every single…

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  • Freyr continues its rapid global expansion: Launching its 5th Regional Hub in Dubai, UAE

    April 2017

    Freyr continues its rapid global expansion: Launching its 5th Regional Hub
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    To reach Life Sciences companies better across Middle East and Africa…

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  • Freyr to offer Strategic Regulatory Services to a Global 700+ million Biopharma Company

    February 2017

    Freyr has recently won a strategic Regulatory services project from a leading India-based, global 700+ million biopharmaceutical company. The project reiterates Freyr’s ever-growing global expertise in offering highly cost-effective, and…

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  • Freyr part of the Top 15 ranking among Top 50 fastest growing technology companies in India

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  • Freyr Wins 'India Knowledge Process Services for Life Sciences Growth Excellence Award' at Frost & Sullivan's GIL 2016: India Awards

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  • Freyr - Finalists of CPhI Pharma Awards 2016

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  • Freyr Expands its Global Footprint in EU

    July 2016

    July 5th, 2016, New Jersey - As an integral part of its global expansion strategy, Freyr establishes its 2nd operations center in Germany (Hanau, Frankfurt-Main) in EU after Maidenhead, UK, leading the company's effort to address the…

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  • Silicon India: Freyr stands as one of the “20 Most Promising Pharma & Life Sciences Solution Providers – 2016”

    May 2016

    4th May, 2016, New Jersey, USA: Freyr makes it to the fore again. Silicon India, a trusted online and print community, has listed Freyr as one of the “…

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  • Freyr bags Strategic Regulatory Intelligence Services Project from a leading Spain based Cosmetics Manufacturing Company

    January 2016

    New Jersey, 28 Jan 2016 - Freyr announced winning a strategic contract from a leading Spain based Cosmetics Manufacturing company for providing Regulatory Intelligence services for Patent Analysis for multiple products across several geographies…

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  • Freyr to Provide Paper to eCTD Submission Services for a US based, Fast growing Medical Instrumentation & Biotech Company

    January 2016

    New Jersey, 28 Jan 2016 – Freyr bags a critical project for providing specialized regulatory submissions services to a US based, Medical Instrumentation & Biotech Company. Freyr will provide its comprehensive support to help the client move…

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  • Experience Freyr in a New Online Version

    December 2015

    New Jersey, 15 Dec 2015 - Freyr announces the launch of its redesigned corporate website www.freyrsolutions.com. As a continuous effort to enrich regulatory professional’s online-informative experience…

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  • Freyr makes the much coveted Top 10 Fastest Growing Healthcare Tech Solution/Consulting Companies 2015 List

    November 2015

    Freyr forges ahead adding yet another milestone to its journey of growth by making the Top 10 Fastest Growing Healthcare Tech Solution/Consulting Companies’ list announced by the Silicon Review publication.

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Publishing and Submissions
Regulatory Labeling

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

Read More

Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

Read More

The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

Read More

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  • Regulatory <span>Affairs</span>
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    • Regulatory Assessment | Gap Analysis
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    • Health Authority Queries – Responses | Interactions
    • Market Authorization Application (MAA) - Article 10 (1)
    • MAA - Post-Approval Submissions
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    • Biosimilars MAA – Article 10(4)
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  • Market Access & <span>Regulatory Intelligence </span>
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  • Publishing & <span>Submissions</span>
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  • Regulatory <span>Labeling</span>
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  • Regulatory<span> Artwork Services</span>
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  • Related <span>Regulatory Services</span>
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  • Industries / <span>Products</span>
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  • Regulatory <span>Software & Services</span>
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