Preclinical Study Design Advisory and Laboratory Coordination
We help organisations plan, design and coordinate preclinical studies — in vitro and in vivo — for natural-health products, working with accredited laboratories and research institutions to generate credible, regulatorily relevant evidence.
What This Practice Covers
Preclinical studies — in vitro laboratory studies and in vivo animal studies — are often a critical component of the evidence base for natural-health products, particularly for regulatory submissions requiring safety and efficacy data. Planning these studies well, selecting the right laboratory partners and ensuring the studies are conducted to appropriate standards is essential for generating credible, usable evidence.
Scope of Practice
What We Provide
Preclinical Study Design Advisory
Advisory on study design for in vitro and in vivo preclinical studies — study type, model selection, endpoints, controls, sample size and statistical approach — relevant to your product and regulatory requirements.
Laboratory Identification and Assessment
Identification of accredited, approved or appropriately qualified laboratories capable of conducting the preclinical studies your evidence plan requires — in India and internationally.
Study Protocol Review
Review of study protocols prepared by laboratories or CROs — assessing scientific rigour, regulatory relevance, endpoint appropriateness and documentation standards.
GLP and Quality Standards Advisory
Advisory on Good Laboratory Practice (GLP) requirements, NABL accreditation standards and other quality standards relevant to preclinical studies for regulatory submissions.
Safety Study Planning
Advisory on safety study requirements — acute toxicity, sub-acute toxicity, genotoxicity, reproductive toxicity and other safety endpoints — for your product and target regulatory pathway.
Efficacy Study Planning
Advisory on efficacy study design — pharmacological activity, mechanism of action, dose-response studies and other efficacy endpoints — relevant to your product claims and regulatory requirements.
Quality and Standardisation Testing Advisory
Advisory on quality testing requirements — identity, purity, potency, stability, microbial limits and heavy metals — and appropriate testing methods for herbal and natural-product matrices.
Preclinical Documentation Support
Preparation of preclinical documentation — study briefs, protocol summaries, study reports and preclinical evidence summaries for regulatory dossiers.
Clients
Who This Practice Serves
Interested in This Service?
Tell us about your project and we will outline how our laboratory and preclinical coordination can support your goals.