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Regulatory Services

Rising demand in matters of registration and licensing

During the last years, there was rising demand in matters of registration and licensing of new products and / or maintenance of traditional licensed products. To deal with this increasing demand, we have expanded our department for registration services continuously.

Our support in regulatory affairs does not end with our classical analytical services and the generation of analytical results and figures.

Beyond that we offer services for the registration of human and veterinary drugs. Historically, GBA Pharma Labs own a special expertise in the approval of herbal preparations and homeopathic remedies.

Benefit from our Experience. We offer:

  • General Advice and Support for Approval of new Products in Human and Veterinary Medicine
  • Access to a Long Expertise in Herbal and Homeopathic Remedies
  • Support for Dossiers Maintenance
  • Processing of Complaints
  • Compilation and Preparation of Dossier Documents in CTD Format and NTA Format
  • DMF (Drug Master File) Creation as ASMF, CMC, CEP
  • Consulting and Support when organising "Scientific Advice" Meetings with the BfArM, AGES, AIFA, and Swiss Medic
  • Contact with the Authorities
  • Discussion on All Aspects of GACP (GOOD AGRICULTURAL PRACTICE AND COLLECTION)
  • Readability User Test

Approval of homeopathic remedies

Registration or approval of homeopathic remedies

For the registration or approval of homeopathic remedies, as for all other remedies, the necessary information regarding the kind and quality of the product must be created and submitted in the CTD format.

However, some special items have to be considered in the case of homeopathics.

It is of major importance to evaluate a suitable strategy for the registration as early as possible and to determine, whether the mother tincture, the first trituration or a certain dilution should be declared as Drug Substance, according with guideline “GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER"

The right decision may have a wide-reaching impact on the finished product line.

Planning stability studies you have to recommend the nature and number of dilutions. These points have major influence on the study protocol (as with reference to “POINTS TO CONSIDER ON STABILITY TESTING OF HOMEOPATHIC MEDICINAL PRODUCTS) For D-Potencies and homeopathic combination products “First Safe Dilution” and “Non-Clinical Safety“ are important key figures. CTD module 3 as well as module 1 also got some other specific items that have to be considered for homeopathic remedies.

From an economic perspective it makes sense to meet the above requirements with established procedures and the necessary expertise to keep the resulting total costs manageable.Choosing a partner like GBA Pharma, with years of experience in the field of registration of homeopathic remedies, you can gain from our support and have significant economic benefits.

Our team is pleased to advise you individually on all matters related to your product.

Talk to us! We look forward to your request.

Readability User Test for Patient Information Leaflets

Readability User Test for Patient Information Leaflets

According to the European drug legislation a testing is mandatory whether the texts of patient information leaflets are understood by the consumer, and whether the consumer is able to appropriately act upon the information. This testing is a precondition for marketing authorizations of medicinal products or their registration. Ultimately the test is a measure for the improvement of consumer safety: its intention is to make the application of a medicinal product as safe and efficacious as possible for the patient.

The readability user test is an essential part of the documentation of dossiers for marketing authorizations of medicinal products. The test must be performed with typical consumer groups.

GBA Pharma can offer you the performance of such tests for the compilation of dossiers for marketing authorizations or drug registrations. Quick, safe and cost-effective. Contact us – we will be happy to advise you.

Plant-Based Medicines

Selection of Plant-Based Medicines

When developing new plant-based medicines or renewing older authorizations, we can support you in the selection of suitable medicinal plants and drugs with a defined level of quality and sustainability, including organic products.

Our operations focus primarily on medicinal products that have been grown in tropical countries associated with the European Union geopolitically. This includes, for example, the French overseas departments and territories such as Martinique, Réunion, and French Guiana. This substantially simplifies the process of importing samples and plant material. Further areas of emphasis involve plants from the Arab and South African regions.

eCTD Service Incl. Submission

Electronic Submission in eCTD Format Now Mandatory for All Regulatory Activities

The obligation to submit drug regulatory information electronically has been continuously extended over the past few years. Initially electronic submission was only mandatory for new marketing authorization applications under the centralized procedure, then it was extended to the DCP/MRP (decentralized / mutual recognition procedure) and to national new marketing authorization applications. As from 1st January 2019, all regulatory life cycle activities have to be submitted electronically in eCTD format.

This also includes all kinds of variations, whether minor or major, all renewal applications, PSUSA submissions, or pharmacovigilance submissions if called for by the authorities.

This is one more milestone in the implementation of the HMA eSubmission Roadmap, which foresees even more electronic functions to be implemented in the next few years.

The regulatory data are submitted in so-called sequences, each starting with sequence no. 0000. Sequences are file bundles managed by an XML file, so that individual documents can be assigned to their right place on the target server and previous document versions can be properly completed, replaced or deleted, if applicable.

These sequences are created by special software systems. GBA Pharma GmbH is of course equipped with such a system and would be glad to create the submission sequences for you – including all preliminary work for submission (variation, renewal etc.).

For existing marketing authorizations, a baseline submission is not mandatory but often helpful and reasonable.

It is not specified which way of submission the marketing authorization holders must use. They may continue to send CDs/DVDs by mail, but the Common European Submission Portal CESP offers a perfect and comfortable way of submission by a simple “drag and drop” operation.

Only parallel imports and standardized marketing authorizations as well as the declaration of renouncement at the end of the life cycle are exempt from mandatory electronic submission.

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs – GMP Testing

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GMP Quality Control

Method Development & Validation

Stability Studies

Dissolution

Extractables & Leachables

Packaging Material Testing

Particle Determination

Elemental Impurities Testing

Microbiology

Amino Acid Analysis

Instrumentation

GMP Testing

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