Regulatory Submissions

Spectrum Regulatory Solutions produces accurate and concise regulatory submission documents which conform to the latest national and international regulations and guidelines.

All our procedures are controlled by SOPs, and our QC/QA services are in accordance with current regulatory standards.

We provide expertise in all therapeutic areas and product types, including pharmaceuticals, biologicals, generics/biosimilars, over-the-counter, herbal medicinal products, medical devices and borderline substances.

We can deliver:

Data Review and Assembly

Spectrum handles CMC regulatory affairs compliance, non-clinical and clinical data packages.

Gap Analyses

With gap analysis for all submissions types, we'll ensure your documentation meets the right requirements for success. Gap analysis helps avoid rejections at the check-in stage, facilitating a more efficient review process.

Common Technical Document (CTD)

Writing, dossier compilation, updates and conversions, eCTD preparation and non-eCTD electronic submissions (NEES) for all CTD modules.

Labelling

Development of Summary of Product Characteristics (SmPC), package labelling and patient information leaflets; labelling harmonisation.

Submission routes

Submissions in all formats for Centralised, Decentralised, Mutual Recognition or National routes of filing in Europe.

Marketing Authorisation Applications

We can assist you with high quality, compliant Marketing Authorisation Applications, Variations, Line Extensions and Renewals.

Authority Questions/RFIs

Following authority reviews, we can expertly field questions for you with compelling, clear and timely responses.

Specialised Applications

Applications for Orphan Drug designation and Paediatric Use Marketing Authorisations (PUMAs).

CTAs

Spectrum will manage your Clinical Trial Authorisation applications effectively.

Regulatory Document Translations

Through our extended network we offer translation of regulatory documentation into all European languages.

We use our extensive experience to ensure that your submission has the greatest chance of successfully negotiating the regulatory hurdles.

Read an example case study

To discuss your requirements, please call us on +44 (0)1403 320280.

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Spectrum Regulatory Solutions, Fraser House, 14 Carfax, Horsham, West Sussex RH12 1DZ regulate@spectrumrs.com. Spectrumrs.com is the trading name of Spectrum Regulatory Solutions Ltd. Spectrum Regulatory Solutions is a limited company registered in England and Wales with company number 5331222. Registered office: St James's House, 8 Overcliffe, Gravesend, Kent DA11 0HJ. VAT registration no: 818283318