Providing Consulting Services to the Pharmaceutical and Medical Device Industries
JH Analytical, LLC, brings broad experience in analytical chemistry, product development and quality management in the pharmaceutical and medical device industries.
We can help address challenges in analytical development, validation and quality control, data integrity reviews/remediation/Part 11 compliance, general laboratory operations/GMP/GLP and in the evaluation of new drug technologies in biodegradable formulations, inhalation and solid oral dosage forms.
Our consultants bring extensive experience in analytical chemistry and product development efforts at Purdue Pharma, Roche Pharmaceuticals, Boston Scientific, Exemplar and Allergan.
Clear, Collaborative Consulting
Our consultants strive for clear, meaningful gap analyses, remediation plans and/or technology evaluations appropriate to the scope and criticality of your projects
We have experience in Quality – compliance assessments, remediation plans, OOS/deviation policies and investigations, data integrity investigations and validation. We design your SOP system and provide all the necessary QMS, QC or lab operations SOPs.
We have experience in Product Development – method development and validation, product performance evaluation, CMC support of drug substance and drug product.
Meet the team
Joseph H. Aiken, Ph.D.
Manager/Owner
Drop us an email to discuss your consulting needs