Tried and tested experts

Biopharmaceuticals

Tried and tested experts in the biopharmaceutical industry

At Woodley BioReg, our team of experienced ex-industry and ex-agency biopharmaceutical and vaccines 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 biopharmaceutical 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 biopharmaceutical sphere — including biosimilars, monoclonal antibodies, vaccines and toxins — below.

Biopharmaceutical service flow

our Biopharmaceuticals 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 candidate molecules in volunteers and patients and form a key part of the clinical development strategy. For biopharmaceuticals, it’s not easily possible to use other techniques and methods in place of clinical trials to compare existing treatments, or to assess treatments in a new or different population group.

/03

Manufacturing

The processes and equipment used to manufacture biological products can be particularly complicated — even more than for pharmaceutical products. We help our clients design manufacturing processes that ensure product yield, purity and bioactivity, and process scalability, while ensuring compliance to all elements of regulatory and quality requirements.

/04

Marketing / Biologic Licence Authorisation Applications

Moving from the clinical development stage to preparing for Biologic Licence Authorisation (BLA) / 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

Biologics Licence Application 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 ensure licence maintenance measures are in place to ensure that approved licences are maintained — ensuring 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 in-house nonclinical, clinical, regulatory, quality, and CMC 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 in-house nonclinical, clinical, regulatory, quality, and CMC 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 in-house nonclinical, clinical, regulatory, quality, and CMC 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 in-house nonclinical, clinical, regulatory, quality, and CMC 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 / Biologic Licence Authorisation Applications

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our in-house nonclinical, clinical, regulatory, quality, and CMC 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

Biologics Licence Application authorisation submissions

We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our in-house nonclinical, clinical, regulatory, quality, and CMC 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 in-house nonclinical, clinical, regulatory, quality, and CMC 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 in-house nonclinical, clinical, regulatory, quality, and CMC 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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