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Welcome to Saigates Scientific Solutions

Your Scientific Advisors

Medicines

As per The Human Medicines Regulation that is followed in the UK, authorisations are required at all stages for medicines meant for human use.

Medical Devices

The MHRA is responsible for appointing UK Notified Bodies and regularly audits them to ensure that they perform to high standards.

Neutraceuticals

Currently, there are regulatory regimes in the EU that cover the following areas: – Foods (EC Regulation 172/2002); – Medicines (Directive 2001/83/ED); and -Foods for Particular Nutritional Use (PARNUTS) (Directive 89/398/EEC)

Borderline Products

MHRA determines whether a product falls within the definition of a medicine – ‘medicinal product’ or a medical device and provides information on whether a product is a medicine or a medical device or not

Cosmetics

In the European Union (EU), the manufacture of cosmetics is governed by the EU Cosmetics Regulation ((EC) No. 1223/2009). The EU Cosmetics Directive (76/768/EEC) and the UK Cosmetic Products (Safety) Regulations are repealed from 11 July 2013

Herbal Medicines

Before marketing a herbal medicine in the UK, application for a traditional herbal registration (THR) has to be made

Saigates Scientific Solution is an FTE based consulting engagement.

We provide impartial consulting services in the area of New Product Development, Formulation Development, Analytical Services, Batch Testing, Regulatory Affairs and Licensing Advisory Services for below products!!! For FREE initial consultation
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Saigates featured solution is a FTE (Full Time Equivalent) based consulting engagement. We engage with companies and provide them with dedicated FTE driven consulting services in the area of new product development, formulation development, analytical services, batch testing, regulatory affairs and licensing advisory services.

Additionally, Saigates also provides product registration/ licensing services for companies which have either developed a new product or is seeking a license to an already registered product which is in the market (generics).

Every engagement is driven along the rules of typical consulting assignment where proposals are drafted based on client requirements. We then work with clients to create concrete project objectives and timelines for different deliverable. We aim to follow agile project management methodologies to achieve resource efficiency and quality within each project.

One FTE is defined as one resource dedicatedly working for 5 days a week at 8 hours a day. We aim to create FTE driven engagement with pharmaceutical companies who are either under-resourced or are looking for ways to reduce R&D costs.

All our clients, and their projects, are unique to their businesses and so we’re always keen to find the right approach for every client project we support.

We do most of our work remotely, at our state-of-the-art office in London; its robust IT infrastructure and high speed broadband mean we can effectively work as an integral part of your team. .

Saigates Scientific Solutions consultants provide support in a number of ways:

  • -Short ad hoc projects
  • -Interim regulatory resource
  • -Long term project management.

The varying levels of expertise and experience at our disposal mean you can be sure that our support will be as cost and work effective as possible; we deploy specific individuals to work on appropriate projects and, if a job is larger or complex, we provide a suitably skilled team.

SSS is committed to deliver projects of outstanding quality that will change how you think about scientific consultancy services. Six core values define how we work. Our consultants will always be: Professional, knowledgeable, personal, passionate, aspirational and innovative.

If you’re working in more specialised areas of regulatory affairs, our large affiliate network of department specific consultants are also able to help.

We do our best to establish a good working relationship with our clients, and are always available to answer client queries.

A New Chemical Entity (NCE) can be defined as “a compound which, previously, hasn’t been described in scientific literature.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

Saigates can present your application for these products to the EMA through the European centralised procedures. This will include the List A which is a mandatory part of the procedure.

A biologically similar medicinal product (biosimilar) is a new biological product that has been developed to be similar to a “reference” product which is already existing in the market.

Advanced therapy medicinal products are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer’s, cancer or muscular dystrophy. They have huge potential for patients and industry.

In the UK, the manufacture and supply of over-the-counter (OTC) medicines is tightly regulated to ensure products are safe, effective and of a high quality.

It is estimated that there are between 5000-8000 rare diseases. These diseases affect around 250 million people worldwide. An Orphan drug is one that has been developed to treat one of these rare conditions.

Specifically, from a regulatory perspective, an orphan drug is a medicinal product for human use that has been designated according to Articles 3 and 5 of the Orphan Drug Regulation, Regulation (EC) No 141/2000

The European Commission introduced the Paediatric Regulation in 2006 to improve the health of children. This ensures that medicines for children are of high quality, ethically researched, and authorised appropriately. You need to submit paediatric investigation plans (PIPs) and paediatric studies under this regulation.

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