Consultancy
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Strategies and Services for
Medicinal Products
Attractive indications and meaningful claims make drugs the most valuable assets in the portfolio. In addition, attractive products with a strong market position can form the basis for portfolio expansions – even beyond the boundaries of marketability and indication areas.
Product care from an experienced hand
We would be pleased to accompany your medicinal products from the product idea through the approval process to quality and lifecycle management including all analytical tasks. Experienced and practice-oriented, in an advisory and executive capacity. The spectrum of our services is always oriented towards the specific concerns and requirements of our customers
On behalf we take responsibility:
- Regulatory Affairs Services / Registrations
- Development and maintenance of QM systems (GMP, GDP)
- Pharmacovigilance
- Clinical & medical assessment
- Drug / batch release as a service
- Audits (incl. API) & inspections
- Quality control & stability testing
- Release test and EU retest
We take over responsible roles:
- Information Officer (acc. to § 74a AMG)
- Graduated Plan Officer (acc. to § 63a AMG / EU-QPPV)
- Responsible Person for Wholesale Trading (acc. to § 52a AMG)
Strategies and services for
Medical Devices
The Medical Device Regulation (MDR) has tightened the regulatory requirements for many established and safe products. Together with you we will find the right strategy for conformity assessment. We support you in assessing for which medical devices of classes I-III in your portfolio the changeover is worthwhile and whether the effort can be reduced, for example, through permissible literature references.
Market access and product maintenance with responsibility
The success and safety of your medical devices are in the best hands with TentaConsult. We create and maintain the necessary documents, documentation and QM systems. In short: We support you in all tasks and decisions up to market access – and also take personal responsibility beyond that.
Assumption of responsibility as Authorised Representative (EC-REP according to Article 11 MDR)
A medical device manufacturer established outside the EU must appoint an Authorised Representative (EC-REP) established in the EU to fulfil the requirements for placing medical devices on the EU market in accordance with the MDR (Article 11).
For these manufacturers, the authorised representative plays a central role as their contact person established in the Union. In case of requests from EU authorities, this authorised representative is contacted and has to ensure that the requests and all required information are provided and handled correctly.
TentaConsult assumes the role of authorised representative and competently handles all related activities and formalities on behalf and in the interest of the manufacturer.
If you are a manufacturer of medical devices that you want to supply to the EU, please contact us and we will talk about a potential cooperation.
Clinical evaluations up to risk analysis
A central aspect of the technical documentation for the conformity assessment procedure is the Clinical Evaluation, for which we prepare, for example, the Clinical Evaluation Plan (CEP) and Clinical Evaluation Reports (CER). With literature-based Clinical Evaluations, we efficiently fulfil the requirements of the Notified Bodies and, if necessary, advise on the design of further studies.
On behalf we take responsibility:
- Conformity assessment procedure
- Classification and demarcation assessment
- Clinical Evaluation Report (CER)
- Risk management
- Biological Evaluation Plan (BEP) / Report (BER)
- Establishment of QM systems (ISO 13485)
- Tests for biocompatibility / biological safety
We take over responsible roles:
- Authorised representative (EC REP) (acc. to Article 11 MDR)
- Safety Officer (acc. to § 30 MPG)
- Person Responsible for Regulatory Compliance (PRRC) (acc.to Art. 15 MDR)
Strategies and Services for
Nutraceuticals
Nutraceuticals balance on the borderline between food supplements and pharmaceuticals in terms of regulation. They are popular with consumers for self-medication and score points with comparatively easy market access – but may only be advertised with health claims to a limited extent. We analyse your product portfolio and explore the opportunities for complementary nutraceuticals.
Product development and maintenance
Already at the earliest stage of the development of your dietary supplements’ formulas, the course is set which will later enable meaningful health claims. It is therefore worthwhile to involve TentaConsult as early as the qualitative and quantitative development of the formula and the evaluation of the ingredients. As specialists in demarcation issues, we know exactly within which parameters we can design your product to guarantee successful market access. And with the highly specialised pharmaceutical and food laboratories of the Tentamus Group, we have the ideal partners at our side for all analytical tasks relating to your product.
On behalf we take responsibility:
- Labelling check
- Marketability check
- FSMP file creation
- Lab Services & Analytics
Strategies and Services for
Cosmeceuticals
The plus of active ingredient that distinguishes a cosmeceutical from a simple care product brings meaningful USPs and added value to the portfolio. But it also brings the cosmeceutical close to the borders of other product categories. We advise you on all questions of demarcation from pharmaceuticals and medical products and support you in the development of effective formulations within the permissible parameters.
Product development and maintenance
During formulation development, we analyse and evaluate active ingredient profiles, active ingredient combinations and suitable auxiliaries within the permissible parameters for cosmetics. We prepare all the necessary documentation to enable your product to enter the market with an attractive and resilient efficacy promise and take over the cosmetovigilance for your products on the market.
On behalf we take responsibility:
- Structure and maintenance of the product information file
- CPNP Notification
- Safety assessment / safety report
- Labelling check
- Quality controls & laboratory tests