AAPS Pharma

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At AAPS Pharma, the clarity meets regulatory compliance in clinical documentation. Our mission is to ensure that the vital data driving your clinical trials is communicated with precision—eliminating risks of misinterpretation and accelerating your path to market approval.

Why Choose AAPS Pharma?

At AAPS Pharma, we combine our client-focused approach with a flexible and scalable operating model to deliver comprehensive medical writing solutions. Our expert team of PhD-level medical writers brings a wealth of experience and impeccable communication skills across all phases of clinical development and a broad spectrum of therapeutic areas. From small molecules to biologics and biosimilars, our tailored services cater to organizations of any size—from emerging biotech startups to leading global pharmaceutical companies.

Our Commitment to Quality and Timeliness

We are dedicated to producing clear, accurate, and submission-ready documents that meet the highest standards of quality. Rigorous internal controls ensure that all clinical documents are delivered on deadline, supporting your trials with efficiency and reliability.

Collaborative Process

Our engagement begins with a detailed discussion to understand your strategic goals, ensuring our writing aligns perfectly with your clinical objectives. From there, we manage all aspects of the medical writing process, including drafting, reviewing, updating, and preparing comprehensive clinical, medical, and regulatory documents.

 

Our Medical Writing Services:

Clinical Study Documentation:

Patient narratives, Investigator’s Brochures, clinical study reports (CSRs), and updates.

Regulatory Submissions:

Clinical Trial Applications (CTA), Investigational New Drug (IND) applications, and comprehensive Common Technical Document (CTD) modules.

Patient and Public Information:

Informed consent forms, patient information leaflets, lay summaries, and web synopses for platforms like clinicaltrials.gov.

Outcome Documentation:

Medication guides, questionnaires, patient diaries, and Patient Reported Outcomes (PRO) documents.

Scientific Communication:

Scientific manuscripts, literature reviews, abstracts, and health authority response documents.

Safety Updates:

Risk Management Plans (RMPs), Drug Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), and Periodic Benefit-Risk Evaluation Reports (PBRERs).

Explore how our medical writing expertise can streamline your clinical trials and enhance your regulatory submissions. Contact us to learn more about our services and how we can assist you in achieving success in your clinical endeavors.