PERITUS - S2PD
Regulatory Affairs Consultancy with Nonclinical Toxicology Safety & CMC Consulting Services for Pharmaceutical and Biotech Development
Peritus S2PD is an action orientated life sciences consultancy providing expert regulatory affairs, nonclinical toxicology safety, and CMC consulting services to pharmaceutical, biotechnology, and medical device companies focused on delivering:
~ Biotech assets from preclinical to CTA/IND as soon as possible.
~ Fixing failing regulatory strategies before Phase II/III.
~ De-risking investor-critical milestones (CTA, IND, MAA).
~ De-risking and expediting Medical Device approval pathways
We support development programmes from early-stage strategy through regulatory submission and approval across global markets.
Our consultants bring deep regulatory affairs and scientific expertise, delivering pragmatic, phase-appropriate solutions that reduce regulatory risk, address development challenges, and support efficient progression of innovative medicines and technologies.
Regulatory Affairs Consulting for Biopharma & Medtech
At Peritus2PD, we help biotech and biopharma companies navigate complex regulatory pathways with confidence. From early-stage strategy through to submission-ready packages, we ensure alignment across CMC, nonclinical, and clinical requirements.
End-to-End Regulatory Support
We provide expert support across:
– IND and CTA preparation and submission
– Regulatory strategy development
– CMC alignment and documentation
– Nonclinical and toxicology gap analysis
– Regulatory writing and dossier preparation
Avoid Delays. De-Risk Your Submission
Most regulatory delays stem from:
– Gaps in nonclinical or toxicology strategy
– Misalignment between CMC and regulatory expectations
– Incomplete or poorly structured submissions
We identify and resolve these risks early — saving time, cost, and rework
Built for Supporting Biotech Startups and SMEs
We understand the pressures of early-stage development:
– Limited internal regulatory resources
– Aggressive timelines
– Investor-driven milestones
Our flexible, expert-led approach integrates seamlessly with your team.
Scientific Advice That Reduces Regulatory Risk
In our experience the most successful development programmes engage regulators early.
Peritus S2PD helps biopharma and medical device companies prepare for and manage Scientific Advice meetings with the FDA, EMA, MHRA and other global agencies. We help you ask the right questions, present your development strategy clearly, and obtain actionable regulatory feedback before critical investment and development decisions are made.
Our experts support:
Early regulatory engagement can identify development gaps, align expectations and reduce the risk of costly delays later in development.
Entering Europe?
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Our Specialist Consulting Services
Regulatory Affairs Consultancy Including Medical Device
Regulatory Strategy Development
EU, UK, & Global Regulatory Submissions (IMPD, CTA, MAA,NDA)
Regulatory Agency Interactions (EMA, FDA, MHRA)
Gap Analysis & Regulatory Risk Mitigation
Regulatory Project Management
Nonclinical & Toxicology Safety, Pharmacology, and Pathology
Nonclinical Regulatory Strategy
Nonclinical Overviews & Expert Reports
IND- and IMPD-enabling toxicology programmes
Safety Pharmacology & Toxicology Gap Analysis
Regulatory Support for Agency Interactions
Chemistry, Manufacturing & Controls (CMC) Consulting
CMC Regulatory Strategy Development
IMPD, NDA, and MAA CMC Support
Manufacturing & Controls Strategy Alignment
CMC Gap Analysis & Risk Mitigation
Regulatory Responses & Variations