Global Regulatory & Clinical Writing Service
Regulatory writing services for drugs and medical devices.
Pepgra offers global regulatory and clinical writing services. The team delivers clinical study protocols and findings with precision. Reports are scientifically accurate, culturally sensitive, and meticulously compliant with regulations and statutory bodies.
Drugs and Medical Devices
Pepgra understands how important it is to write in a manner that is understood by statutory reviewers and regulatory bodies such as EMA (EU), FDA (USA), PFB (Canada), PMDA (Canada), TGA (Australia), MCC (South Africa), ASIAN (Hong Kong), GCC, CIS (Russia) and many other regulators. Moreover, delays and additional revisions can have significant cost implications. Our regulatory medical writing services will help you in composing well-written regulatory documents and ensure that your dossier is reviewed, edited and proofread thereby saving you time and money. Pepgra writers work closely with your statisticians, regulatory and data management teams to deliver meticulous documents that are on par with the highest standards.
Regulatory & Clinical research writing experts have the capabilities and skills to prepare regulatory submission documents required to seek approval for drugs (Abbreviated New Drug Application – ANDA), devices and nutraceuticals (for health claims). The regulatory medical writing solutions we offer include regulatory compliance solutions in preparing essential documents for clinical trial submissions such as investigator brochures (IBs), protocols, dossier development including common technical documents (CTDs), eCTD modules, periodic safety update reports (PSURs), development safety update reports (DSURs), annual safety reports (ASRs), clinical study reports (CSRs), documents related to pharmacovigilance like risk management plans (RMPs), periodic safety update reports (PSURs) and other associated documents.
Pepgra Extensive Regulatory Experiences
Our comprehensive solutions for pharmaceutical companies
Full dossier development
Pepgra CRO team has extensive knowledge of Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics who can facilitate trial life cycles by establishing efﬁcient processes that reduce costs and deliver a rapid return on investment.
For medical device manufacturers
We offer pre-market Conformité European (CE) mark report, clinical data, and post-market studies. Pepgra has extensive experience in preparing following reports for Class I (low risk), IIa, IIb, and III (high risk): For medical devices, we are compliant with Medical Device Academy (MedDev) 2.7/1 Revision 4 guidelines to perform the clinical evaluation.
Our Expertise and Experience
Other guidelines include the following: Association of the British Pharmaceutical Industry (ABPI), Standards for Reporting of Diagnostic Accuracy (STRAD), ICH, FDA, and MedDev.
Our regulatory medical writers hold vast experience in handling a wide range of therapeutic areas and all phases of development that are sound from both a scientific and regulatory perspective.
Pepgra has done plethora of work in the area of clinical and regulatory writing for top pharmaceutical and medical device companies. Our writers are certified and comply with international regulatory standards when preparing your reports.
We deliver study designs that are balanced to meet your business needs with the current scientific understanding and regulatory requirements. Partner with us to get your clinical and regulatory reports.
Allow us to help propel your product forward.
At the outset, I knew with the mammoth project on hand, we did not have the bandwidth to focus on writing and preparing reports. However, I worked with the team at Pepgra and they executed my work with finesse and aplomb. So leave the writing to them if you want to hit the market and get drug approvals fast. What a professional team at Pepgra!
— John Doe, CEO of a leading pharma company.
up as your needs grow.
No compromising on integrity and quality. Our processes are well defined and flexible to ramp up as per your requirements.
you till the project end.
We come with you all the way. From design to market support
Pepgra CRO Offerings
"Changing global regulatory system, globalization of clinical trials, increased consumer expectations, infrastructural and culture issues, and various diagnostic requirements should never hamper your research and development programs. With our support..."
Download brochure on our CRO offerings (PDF).