Tried and tested experts

Pharmaceutical

Tried and tested experts in the pharmaceutical industry

At Woodley BioReg, our team of industry and agency-experienced consultants can support you every step of the way — from defining your Target Product Profile (TPP) and preclinical / nonclinical development, through to licence submission, approval and maintenance.

With our combined expertise spanning many decades, we can help to develop and refine your regulatory and quality strategies to ensure a smooth and speedy journey to get your pharmaceutical products to market efficiently.

And, with our insight into the ways in which regulatory agencies operate around the world, we can assist you in planning for success, right from the start.

Discover all of the services that we offer to clients operating in the pharmaceutical sphere below.

Pharmaceutical service flow

our Pharmaceutical services

360 Value

/01

Preclinical / Nonclinical

Preclinical (nonclinical) development refers to the process through which investigational drugs are subjected to extensive laboratory testing to determine their safety for humans.

/02

Clinical Development

Formally reviewed and approved clinical trials are used to determine the safety and efficacy of a candidate drug in volunteers and patients and form a key part of the clinical development strategy. Where it’s not easily possible using other techniques and methods, clinical trials can be used to compare existing treatments, or to assess treatments in a new or different population group.

/03

Manufacturing

The processes and equipment used to manufacture medicines can be complicated — after all, patient safety is at risk when mistakes are made. We help our clients design manufacturing processes that ensure product yield and process scalability, whilst ensuring compliance to all elements of regulatory and quality requirements.

/04

Marketing Authorisation Applications

Moving from the clinical development stage to preparing for Marketing Authorisation (MA) can seem daunting, but with structured and tailored support from our regulatory consultants at Woodley BioReg, the process can be painless.

/05

Marketing Authorisation Submissions

At Woodley BioReg, we provide comprehensive publishing and portal submission services including Non-eCTD electronic submissions (NeeS) and electronic Common Technical Document (eCTD).

/06

Maintenance

Following approval, Marketing Authorisation Holders (MAHs) must implement licence maintenance measures to ensure that approved licences are maintained — protecting patient safety at all times.

/07

Supplementary Services

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.

/01

Preclinical / Nonclinical

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.
/02

Clinical Development

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.
/03

Manufacturing

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.
/04

Marketing Authorisation Applications

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.
/05

Marketing Authorisation Submissions

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.
/06

Maintenance

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.
/07

Supplementary Services

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.
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