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Freelance translator and/or interpreter, Verified member
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Services
Translation, Editing/proofreading
Expertise
Specializes in:
Law (general)
Business/Commerce (general)
Law: Contract(s)
Law: Patents, Trademarks, Copyright
Law: Taxation & Customs
Human Resources
Finance (general)
Social Science, Sociology, Ethics, etc.
Science (general)
Advertising / Public Relations
Also works in:
Accounting
Economics
Government / Politics
Insurance
Manufacturing
IT (Information Technology)
Education / Pedagogy
Agriculture
Telecom(munications)
Cosmetics, Beauty
Cinema, Film, TV, Drama
Psychology
Media / Multimedia
Other
More
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Blue Board entries made by this user
1 entry
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Portuguese to English: Indeferimento de processo General field: Law/Patents
Source text - Portuguese I. Os formulários de petição (FP2) enviados estão incompletos. Os campos de nº 35, 37 e 38 não foram preenchidos. A ausência de informação inviabiliza a análise do documento. De acordo com inciso II do § 2º do artigo 2º da RDC 204/2005, as petições somente poderão ser passíveis de diligências com vistas a informações e esclarecimentos. Não é o caso, pois não houve dúvidas quanto à documentação, mas ausência de dados. Portanto não cabe a emissão de exigência. De acordo com parágrafo único do artigo 2º da RDC 204/2005, a conclusão da análise em virtude de documentação insatisfatória,neste caso entenda-se incompleta, enseja no indeferimento do pleito.
II. Não foi apresentado laudo de controle de qualidade referente à droga vegetal realizado pelo fornecedor do insumo. Constam apenas os laudos realizados pela fabricante do medicamento. A documentação é cobrada por meio do artigo 14º da RDC 26/2014. Não foi exarada exigência, uma vez que,conforme inciso II do §2º do artigo 2º da RDC 204/2005, não são passíveis de exigência as petições que não estiverem instruídas com a documentação exigida quando do seu protocolo. De acordo com o parágrafo único do artigo 2º da RDC 204/2005, a insuficiência da documentação técnica exigida quando do protocolo da petição resulta no indeferimento da petição.
V. Os métodos de identificação relacionados ao controle de qualidade dos insumos Primula veris/Primula elatior e Rumex crispus carecem de validação por não serem compendiais. Assim como todos os métodos de doseamento também relacionados ao controle de qualidade dos insumos ativos. Não foram apresentadas as validações relacionadas aos métodos supracitados. Conforme parágrafo único do artigo 11º da RDC 26/2014, quando não forem usadas referências farmacopeicas reconhecidas pela ANVISA, os métodos devem ser validados frente à RDC 899/2003. Este item resulta no indeferimento do pleito sem a emissão de exigência pelo mesmo motivo já explicitado nos itens anteriores.
Translation - English I. The petition forms (FP2) submitted are incomplete. The fields numbered 35, 37 and 38 were not filled in. This lack of information renders the document analysis unfeasible. According to clause II of paragraph 2 of article 2 of RDC 204/2005, petitions may only be accepted in proceedings for information and clarification purposes. In this case, there was no doubt about the documentation, but rather, the lack of data. Therefore, the requirements have not been met. According to the sole paragraph of article 2 of RDC 204/2005, the analysis cannot be completed due to the unsatisfactory documentation, which has led to the rejection of the lawsuit.
II. A quality control report in reference to the herbal substance was not presented by the supplier of the raw materials. Only reports produced by the drug manufacturer are included. The documentation is required in accordance with article 14 of RDC 26/2014. However, no requirement was raised since, according to item II of §2 of article 2 of RDC 204/2005, petitions that are not requested as part of the documentation required are not eligible under the court’s protocol.
V. The identification methods related to the quality control of the raw materials Primula veris/Primula elatior and Rumex crispus require validation as they are not comparable. In the same way as the dosing methods related to the quality control of the active raw materials. Validations related to the aforementioned methods were not presented. According to the sole paragraph of article 11 of RDC 26/2014, when pharmacopoeial references recognized by ANVISA are not used, the methods must be validated against RDC 899/2003. This item results in the rejection of the lawsuit without issuing a requirement for the same reason already explained in previous items.
English (Birkbeck College (Univ. of London), verified) Portuguese (Birkbeck College (Univ. of London), verified) French (Birkbeck College (Univ. of London), verified) Portuguese to English (Birkbeck College (Univ. of London), verified) French to English (Birkbeck College (Univ. of London), verified)
Memberships
N/A
Software
Adobe Acrobat, memoQ, Microsoft Office Pro, Microsoft Word, SDL TRADOS, Wordfast
I have been working as a translator since 2010 and have undertaken a variety of projects ranging from press releases to employment contracts. Most of my recent projects have been in the business and legal fields. Examples of documents that I regularly translate include contracts (employment, distribution, compensation plans), legal notices, articles of incorporation, terms & conditions, company reports, financial statements, press releases, etc.
My typical translation output is 3000 words per day and I work with SDL Trados and memoQ software.
I hold an MA in Spanish, Portuguese and Latin American Cultural Studies and a BA in Modern Languages (Portuguese and French) from the University of London. My primary and secondary schooling was completed in Portugal where I have also worked as a dive centre manager and as a sales representative for a publishing company.
If you are interested in working with me, please contact me for a quote.
Keywords: native english speaker, based in the UK, Portuguese, português, English, inglês, law, finance, economics, accounting, business, trade, commerce, contracts, contract, law, litigation, legal, documents, public tender, invitation to bid, legal documents, corporate documents, financial statement, annual reports, articles of organization, articles of incorporation, limited liability company, joint-stock company, business partnership, social sciences, arbitration, direito, finanças, economia, contabilidade, comércio, negócios, contratos, licitação, concurso público, leilão, documentos societários, demonstrações financeiras, relatório anual, sociedade limitada, sociedade anónima, pessoa jurídica, arbitragem, Portuguese Translation, Portuguese Translations, Portuguese to English Translator, Portuguese to English Translation, Portuguese to English Translations, Portuguese to English Translator, Traduções, Traduções Português Inglês, contratos, jurídico, patents, patentes, business, negócios, comércio, government, governo, organizations, organizações, copyrights, direitos de autor, defense, defesa, criminal, international, internacional, portuguese, português, portugués
Member since May '17
Expertise