New Product Development
Ransom Naturals Limited (RNL) are highly regarded as the Company to go to for new product development (Npd) opportunities. We start by evaluating the project in full including appropriate background literature research along with an EH&S assessment. RNL provide a detailed overview of the proposed work and a cost quotation.
Where required method development is undertaken to ensure there are appropriate stability indicators in place and robust in-process controls guarantee the quality of the end product. These controls are underpinned by clear and compliant measures for cleaning as well as storage/packaging evaluation. Nothing is left to chance when ensuring the product meets all the regulatory requirements when compiling the Active Substance Master File (ASMF) for a successful submission. A development laboratory procedure is generated and this forms the basis for scale up, raw material and product specification along with limits for in-process controls. This means critical quality controls are in place and critical quality parameters are clear.
The Regulatory team at RNL work on herbal drug product development as well as analytical methodology to ensure the appropriate chemical manufacturing quality controls are in place for commercial manufacturing. We meet GMP compliance and global Regulatory requirements.
The Herbal Medicinal Product Committee (HMPC) issues scientific opinions on herbal substances and preparations, along with information on recommended uses and safe conditions, on behalf of the European Medicines Agency (EMA). In many markets, Herbal Medicinal Products (HMPs) HMPs must now meet same regulatory standards as synthetic Active Pharmaceutical Ingredients (APIs) unless sound scientific justification is provided during the ASMF submission.
There are three main Regulatory path ways for herbal pharmaceutical submissions:
- Traditional use
- Well-established use marketing authorisation
- Stand-alone or mixed application
RNL take a very structured approach to developing these HMPs which ensures they meet all applicable regulatory submission standards as per the required National Competent Authority (NCA).
The approach consists of 4 gates:
- Gate 1: Development and deliverables
- Gate 2: R&D to Scale up preparation & deliverables
- Gate 3: Scale up/ Process optimisation and validation & deliverables
- Gate 4: Compilation of ASMF & Submission followed by RFI response preparation / response
A manufacturing process is developed as per the customer request ensuring all the necessary method requirements are fulfilled.
The appropriate analytical controls are very important in order to control the quality of the finished product and meet stability indicating method requirements. Generally HPTLC, HPLC, wet chemistry assay method, NMR, LC-MS, GC, particle size analysis or related analytical techniques will be used to develop a method, followed by method validation.