Regulatory Affairs Consulting & Strategy

Spectrum's team of professionals has worked with pharmaceutical companies and CROs of all sizes and has interacted with regulatory authorities worldwide.

We are equipped with the organisational structure, experience, contacts, responsiveness and negotiation skills to handle your project successfully.

Fast and innovative response to problem-solving is standard, but pro-active avoidance of the pitfalls brings added value to our service.

We can deliver:

Optimal European Filing Strategy

We give you guidance on procedures and processes for pharmaceutical products as well as advice on medical device regulation, helping you plan optimal routes to market.

Regulatory Compliance & Submissions

Meet your submissions requirements efficiently with advice from experienced consultants.

Regulatory Agency Negotiations

We prepare for, advise on, or undertake on your behalf, liaison with the European Medicines Agency (EMA) and National Competent Authorities to facilitate approval of your submission.

Orphan Drug Designation

Avoid delays in obtaining designation for Orphan Drug status - we can help with all stages of your application.

Paediatric Investigation Plans & Marketing Authorisations

The value and benefits of 10 years of marketing protection speak for themselves. Spectrum can help you develop Paediatric Investigation Plans (PIPs) and to obtain Paediatric Use Marketing Authorisations (PUMAs).

Changes in Legal Status

We have a proven track record in preparing successful switch applications.

Due Diligence

Avoid costly pitfalls in licence acquisition through advice and guidance from experienced consultants.

Read an example case study

To find out more about how Spectrum can benefit your project, download our brochure or call us today.

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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