regulatory...analysis/documentation of block diagrams, schematics, blueprints, ﬂow diagrams, etc.,...

REGULATORYLIST OF SERVICES

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REGULATORY SERVICES LIST

MEDICAL DEVICESCOSMETIC

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MEDICAL DEVICESREGULATORY SERVICES LIST


WHAT KIND OF SERVICES DO WE OFFER?

Please click on the following areas:

MEDICAL DEVICES REGULATORY

Facilities licensing Other ServicesProduct Dossier Quality system

We advise our clients with the best strategy adapted to their specific needs, ensuring that

organizations comply with all applicable regulations.

Implementation, maintenance and

improvement of the quality system according to

ISO 13485.

Procedure, maintenance, modification, extension and updating of prior

licensing of the operation of installations of medical devices

AuditsContact and request for processing with health

authorities (AEMPS, FDA, COFEPRIS, INVIMA, etc.)

and Notified bodies.Among others...

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ZURKO MEDICAL DEVICES REGULATORYSMART SOLUTION

PRODUCT DOSSIER01

QUALITY SYSTEM

02

FACILITIES LICENSING

03

OTHER SERVICES

04

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PRODUCT DOSSIER 1/301

• Directive 93/42/CEE and MDR 2017/745 to obtain CE

marking.

• FDA: Premarket Notification submission 510(k) and/or

Premarket Approval Application (PMA).

• Requirements for various markets in LATAM

Development of technical dossier/dossier of medical devices according to:

Revision/adaptation of TF:

•Revision of the already developed technical dossier and its associated annexes, contact with the owner of the company to correct any deficiencies and/or adaptation to policy requirements.

a

b

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Collection and assessment of documentation for assembly of the file:

c

Descriptive documentation.

Review classification.

Declaration of conformity, CE marking.

Analysis/documentation of block diagrams, schematics, blueprints, flow diagrams, etc., and explanations required for its understanding.

Analysis of documentation of manufacturing methods:

- Diagram of the flow process manufacturing, manufacturing facilities, machinery, and tools.

-Written procedures. Instructions for work.

-Roadmap/process sheet. Inspection and testing records. Batch file.

Review of product verification documentation, Biocompatibility.

Review of the functionality documentation: reports of use, clinical evaluation, clinical bibliography.

Cleaning requirements and microbiological controls. Cleaning and sterilization processes.

Instructions for use, installation, and maintenance. Labeling. Use of graphical symbols.

Preparation/review of procedure for the validation of processes.

Revision of tests performed. Applicable and applied regulations.

Review of assays in-process and end of the product.

Advice/Review risk analysis. Risk Management

Preparation/review Analysis of essential requirements.

Postmarketing monitoring

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Communications

Register of liability on the market for medical devices (RPS).

Marketing and/or putting into service of medical devices (CCPS).

Distribution communication of medical devices

d

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QUALITY SYSTEM02

Implementation, maintenance and improvement of the quality system according to Iso 13485

Advisory to implement a quality system based on EN ISO 13485 and its subsequent certification by ON:

Quality manual (operation review/ enterprise management, Identification responsibility for the operation, quality policy. Mission, vision, Chart updated, functions attribution. Job profiles, process identification, quality manual).

Documentation of procedures ( Departments included: Admi-nistrative, commercial, production, quality, warehouse, etc.)

Instructions for work and control patterns (identification of productive processes, the model of work instruction/control pattern, control pattern, final testing, internal calibration instruction).

Quality plans (quality plans, quality policy, training, calibra-tion, maintenance, etc …).

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FACILITIES LICENSING03

Procedure, maintenance, modification, extension and updating of prior licensing of the operation of installations of medical devices

Advisory to the request for the license of medical devices in accordance with Rd 1591/2009 and circular 22/99 and its processing to the AEMPS.

Documentation checks required for the application for the license of the manufacturer of medical devices (documenta-tion of installations, organizational, own working procedures and subcontracted undertakings relating to manufacturing, storage, marketing, etc.)

Facilitation of formal documentation models.

Revision of contracts and interaction procedures with suppliers, subcontractors and control laboratories.

AEMPS portal management for compliance with require-ments for manufacturing facilities.

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OTHER SERVICES 1/3

Auditsa

Contact and request for processing with health authorities (AEMPS, FDA, COFEPRIS, INVIMA, etc.) and Notified bodies.

b

Preparation, creation of documentation and accompanying during auditoriums of health authorities, notified bodies and customers, including product audits, quality system, etc.

Support in the resolution of non - conformities identified during the audit process, by guidance on the resolution of the audits, the development of supporting technical documentation, etc.

Conduct internal audits and external audits to critical suppliers at national and international levels:

Documentary: Review of documentation disposition required by ISO 13485

- Quality Manual.- Procedures and records.- The flow of operations and processes diagrams.- Instructions for work.- Quality plans (assurance, training, validation, calibration, etc.).

Implementation: facilities review on-site for the assessment of the standard.

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04

OTROS SERVICIOS 2/3

Training in regulations, guides, standards, ISOs, etc., related to medical devices.

c

Assessment of product viabilityd

Preliminary evaluation of the product/s, definition of marking strategy, testing consultancy and finding the most appropriate claim for proper classification and processing according to existing regulations.

Assessment Report for biocompatibilitye

Bibliography and revision of articles, as well as the development of the biological evaluation report (BER) according to ISO 10993-1:2018

Clinical evaluation for bibliographyf

Evaluation for scientific publications: Search for various databases on equivalent product publica-tions and for the same claim, which has data concerning the performance and safety of these products.Preparation of clinical evaluation report in accordance with the recommendations of the guide MEDDEV. 2.7.1 Rev. June 4,2016

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OTROS SERVICIOS 3/3

Advice for regulatory compliance with tests g

Preclinicians according to Iso 10993 for assessment of Biocompatibility of medical devices.

Clinics according to good clinical practice (ICH Topic E6, CPMP/ICH/135/95 and Guías del Parla-mento y del Consejo 2001/20/CE) and guide MEDDEV 2.7.1 Rev.

Application for a certificate of Libre Vente (CLV) For exports of medical devices via the CERTPS platform.

g

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COSMETICREGULATORY SERVICES LIST



WHAT KIND OF SERVICES DO WE OFFER?


COSMETIC REGULATORY

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Communications Other servicesProduct dossierImport. Good manufacturing practices

Processing, maintenance, modification, extension and

updating of the declaration responsible for manufacturing and importing activities of a

cosmetic productImplementation, maintenance

and improvement of the system of good manufacturing practice

according to ISO 22716

Development of information files on the

cosmetic product according to Regulation

(CE) 1223/2009Revision/adaptation

of PIF

Notification to the European cosmetic products portal

(CPNP) before the product is introduced

into the market.Presentation of the

declaration responsible for the manufacture... ETC.

Tailor-made regulatory attention.

Creation and modification of safety data sheets

“Material Safety Data Sheets” (MSDS).

Among others...

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ZURKO COSMETIC REGULATORYSMART SOLUTION

IMPORT AND MANUFACTURING BP

01PRODUCT DOSSIER

02

COMMUNICATIONS

03

OTHER SERVICES

04

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Responsible Statement for activities manufacturing and importing cosmetic products

Processing, maintenance, modification, extension and updating of the declaration responsible for manufacturing and importing activities of a cosmetic product

Advisory for the request of the Responsible Statement for the manufacturing and importing of cosmetic products covered by Article 69 of law 39/2015 of 1 October of the general administrative procedure of the general government.

1) Documentation check required for the application of the Declaración Responsable manufacturer of cosmetic products:

•Data of the owner of the activity, data of the qualified person, activities referred to in the responsible declaration, whether they are carried out materially by the owner or carried out by subcontracted companies: manufacture of bulk, conditioning (packaging and labeling), control, storage, and import.•Facilities/plant data where activities carried out materially by the holder of the responsible statement shall be carried out. •Categories and cosmetic forms which are the subject to activities, in the case of manufacturing activity.•Declaration of the holder of the activity complying with the requirements and obligations inherent in the exercise of the manufacturing and/or import activity set out in the annex to royal decree 85/2018 of 23 February, which results in the application and commitment thereto throughout the exercise of the activity.

01

a

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IMPORT AND MANUFACTURING BP 2/4

Responsible Statement for activities manufacturing and importing cosmetic products

Processing, maintenance, modification, extension and updating of the declaration responsible for manufacturing and importing activities of a cosmetic product

Advisory for the request of the Responsible Statement for the manufacturing and importing of cosmetic products covered by Article 69 of law 39/2015 of 1 October of the general administrative procedure of the general government.

2) Fee payment:•These are the rates for the verification of the declaration responsible for the initiation of activities or substantial modification of activities carried out by the company holding the declaration (own activities), as set out in the Royal legislative decree 1/2015 of 24 July, and are updated annually by the general state Budget Act.

3) Management of the AEMPS portal for the fulfillment of requirements for the declaration responsible for manufacturers of cosmetic products.4) Provide models of the declaration responsible for the manufacture and/or import of cosmetic products.

01

a

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Conformity certificates for good manufacturing practices

Implementation, maintenance and improvement of the system of good manufacturing practice according to ISO 22716

Advisory Counsel to implement a system of good cosmetic product manufacturing practices (GMP) according to UNE - EN - ISO 22716: 2007.

1)Comply with legal requirements in Spain. UNE-EN Standard. ISO 22716:2007, the Cosmetics Regulations (R.D.1599/1997). Article 6 and the European Cosmetics Regulation 2009, harmonized standards, Article 8 and 12.2) Conformity of premises and equipment:

•Staff: organization, main responsibilities, training and skills, hygiene and health of staff.•Premises: Design: areas, space, and flows; floors, walls, ceilings, and windows; bathroom and toilet; lighting and ventilation; pipes, drains, and pipelines; cleaning and disinfection; maintenance, consumables, and pest control.•Equipment: design of equipment; installations; calibration; cleaning and disinfection; maintenance; consumables; authorizations and alternative systems.•Raw materials and conditioning material: purchases, reception; identification and situation; liberation; storage; re-evaluation; water quality used in production.•Production: manufacturing and conditioning operations.•Finished products: release; Storage; shipping and returns.

01

b


Conformity certificates for good manufacturing practices

Implementation, maintenance and improvement of the system of good manufacturing practice according to ISO 22716

Advisory Counsel to implement a system of good cosmetic product manufacturing practices (GMP) according to UNE - EN - ISO 22716: 2007.

3) Laboratory, quality control, and deviations: •Test methods; acceptance criteria; results; reagents, dissolutions, reference patterns, the culture of crops; sampling; display of archives; product treatment off specifications; deviations.

4) Product and withdrawal claims from the market5) Outsourcing and waste.6) Change control.7) Internal audit and documentation:

•Internal Audit: approach and follow - up;•Documentation: type of documents; drafting, approval, and distribution; review and archiving.

01

b


PRODUCT DOSSIER 1/2 Safety evaluation, Information file on product and notification

Development of information files on the cosmetic product according to Regulation (CE) 1223/2009

Report on the safety of a cosmetic product - Compilation and revision of Assembly documents for part A.. Information on the safety of the cosmetic product (the quantitative and quantitative composition of a cosmetic product, physical characteristics and stability of the cosmetic product, microbiological quality of substances, mixtures and finished product, impurities, traces and information on packaging material, normal and reasonably foreseeable use, exposure to a cosmetic product, exposure to substances, the toxicological profile of substances, unwanted effects and serious undesirable effects, information on the additional cosmetic product).- Clear identification and quantification, based on identified hazards, the risks that a cosmetic product may represent for human health. - Conclusion for part B: Safety assessment of the cosmetic product. Product safety assessment taking into account all hazards identified for and exposure to the product (conclusion of the evaluation, labeling with warnings and instructions for use, reasoning)

Revision of labeling and adaptation to regulatory changes.

02

a

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02

Revision of the PIF already elaborated, address shortcomings and adapt to policy requirements.

Revision/adaptation of PIF b

Substance toxicology profile: - Preparation of the report on the safety of the cosmetic product: description of the toxicological hazard of each substance in the finished product, determination of the potential exposure and development of risk characterization.

Advisory on testing demonstrating the claims of cosmetic products according to Regulation (EU) 2013 of the commission of 10 July 2013 laying down the Common criteria for which the claims concerning cosmetic products are to be met.

Development of information files on the cosmetic product according to Regulation (CE) 1223/2009

a

PRODUCT DOSSIER 2/2 Safety evaluation, Information file on product and notification

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COMMUNICATIONS

Notification to the European cosmetic products portal (CPNP) before the product is introduced into the market.

03

a

Presentation of the declaration responsible for the manufacture and/or import of cosmetic products before the start of the activity or of the amendments in the same way to AEMPS.

b

Application for a certificate of compliance with good practices for the manufacture of cosmetic products to AEMPS.

c

Application for cosmetics certificate primarily for export to AEMPS.

d

Notification of nanomaterials to the European cosmetic products portal (CPNP).

e

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Tailor-made regulatory attention.a

Creation and modification of safety data sheets “Material Safety Data Sheets” (MSDS).

b

Notification/Declaration/register of raw materials and products.c

Advice on products with substances in the form of nanomaterialse

d

04

OTHER SERVICES 1/3

Consulting in ingredients and natural and organic cosmetic products according to UNE-ISO 16128-2:2019

Determination of natural content, natural origin, organic and of organic origin products

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Registration, evaluation, and authorization of chemicals (REACH), application of the regulation (CE) no 1907/2006

f

Comply with the Reglamento of CLP, regulation (CE) Number 1272/2008 of the European Parliament and of the Council on 16 December 2008 on the classification, labeling and packaging of substances and mixtures and amending and repealing directives 67/548/CEe and 1999/45/CE and amending Reglamento (CE) nº 1907/2006. Notification to the National Institute of toxicology and forensic Sciences (INTCF).

g

Risk assessment of the packaging.h

Regulatory advice for cosmetic product claims.i

04

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Support for carrying out adequate cosmetovigilance.j

Contact and request for processing with health authorities (AEMPS, FDA, etc.) and notified bodies.

k

Training in regulations, guides, standards, ISOs, etc., related to cosmetic products.

l

Advice with the requirements of "cosmetic customized products”.

m

Design and implementation of strategies for implementing national, European and international regulations.

n

04

OTHER SERVICES 3/3

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regulatory...analysis/documentation of block diagrams, schematics, blueprints, ﬂow diagrams, etc.,...

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