Pharmaceutical and Healthcare Consulting Services

Discovery, Development and Regulatory Solutions for the Medical and Pharmaceutical Industries

Primetime’s experts provide assistance at all phases of drug development to our partners in the pharmaceutical, biotechnology, and medical device fields. With diverse and in-depth experience, our team of scientists and regulatory affairs specialists provides expert advice and services related to medicinal chemistry, nonclinical safety testing, manufacturing, clinical trial design, submission preparation and regulatory agency interactions to make a success. We provide cost-effective and quality outsourcing solutions with our experience in working with CROs in the United States, Canada, Europe, and Asia.

Medicinal Chemistry

We can provide expert guidance on early stage projects (hit to lead), lead optimization programs and development candidate selection. Our expertise is in medicinal chemistry, improving drug like properties and bioavailability.

We offer:
  • Intellectual property strategy
  • Lead Identification and Lead Optimization
  • Candidate Selection
  • In depth review of programs
  • Due diligence services


Primetime provides expert toxicological and regulatory consulting services to pharmaceutical, biotechnology, and medical device companies. We have many years of industry experience provide solutions to complex development, toxicological, and regulatory issues, through the combined expertise of scientific and regulatory experts located worldwide.

We offer:
  • Design, implementation, and management of nonclinical testing programs with a focus on company goals
  • Review, interpretation, and positioning of data (toxicology study reports, literature, safety data)
  • Toxicology issues resolution, including interactions with regulatory authorities and the preparation of responses
  • Gap analysis and independent data reviews
  • GLP study monitoring, including pre-placement and in-life study audits

Product Development

Primetime can provide development strategies for pharmaceutical and medical products, ranging from lead candidate selection to final regulatory submissions and post-market activities. We evaluate realistic product development strategies meeting international standards, focusing on regulatory and toxicology requirements.

We offer:
  • Nonclinical studies required for regulatory approvals
  • Management and resolution of CMC issues
  • Project planning for regulatory submissions and development activities
  • Preparation, review, management and filing of IND and NDA submissions
  • Compliance activities, including development of compliance programs and conduct officiality audits for adherence to GLP and GMP standards

Pharmaceutical Regulatory Affairs

Primetime provides scientific and regulatory consultancy services for the medical and pharmaceutical industries.

Our qualified and experienced regulatory affairs experts can provide your business with consulting advice from the early pre-IND/pre-CTA/pre-IDE stage of development through to marketing applications.

We offer:
  • Preparation of IND, NDA, ANDA and CTA submissions
  • CMC submission writing, organization, assembly, quality review and filing
  • Meeting assistance including scientific advice requests, materials, preparation and follow-up
  • Liaison activities to global regulatory authorities
  • CMC submission critique and assessment
  • Agent representation to FDA and European agencies
  • Dedicated RA professional to work closely with you to meet your submission needs
  • Post-approval support (supplements, amendments, annual reports, manufacturing and material change assessments)