Artificial intelligence (AI) has changed several industries recently, and the digital advertising sector is no exception due to its rapid development. AI has fundamentally altered…
NON CLINICAL WRITING SERVICES
Smiqgen offers authoring services for all phases of clinical research. The expert writers have in-depth knowledge in all non clinical development.
CLINICAL WRITING SERVICES
Authoring all clinical documents with highest quality. Smiqgen have significant experience in regulatory submission and the expert writers have in-depth knowledge about the regulatory guidelines and ensure timely submissions.
PV AGGREGATE WRITING SERVICES
Smiqgen offers services to maintain compliance in all post marketing submission commitments. We develop good quality aggregate reports with minimal or no regulatory questions.
Smiqgen provides quality review services for regulatory documents. The review team at Smiqgen comprehensively reviews the regulatory documents for data integrity, consistency, misrepresentation, ambiguity, accuracy, authenticity, and structure and format of the documents according to regulatory guidelines.
Smiqgen offers the service for developing safety narratives as a part of cardiovascular regulatory dossier submission. We also provide the solutions to your regulatory challenges in filing regulatory documents of the cardiovascular drug by performing a quality check and editing, wherever necessary.
Metabolism and Endocrinology:
If you are preparing to file the regulatory documents for a drug targeting the metabolic or endocrine disorder, Smiqgen can help you in final checking of the consistency and accuracy of results. Further, we also help you in writing the dossier and editing the documents for the format, spelling mistakes, and ambiguous information.
The regulatory writers, reviewers, and editors at Smiqgen have helped large international healthcare organizations in submitting the regulatory dossiers related to immunology drugs. We have the required expertise in developing patient safety narratives and helps the client in developing documents of clinical trials at all phases.
Oncology (including immune-oncology):
Smiqgen has regulatory writers with several years of experience in authoring and reviewing of all types of oncology documents. We help the healthcare organization in authoring the clinical trial protocol and study results at all phases of trials related to cancer drugs. Our oncology writing experts also review and edit the regulatory documents.
OUR UNIQUE STRATEGY
Smiqgen has a unique strategy for delivering high-quality regulatory documents. We completely understand the client's requirement and seek additional information, if required. Once we develop the first draft of the document, we send it to the client to ensure that it meets their requirements. We also revise the documents based on the client's feedback.
Smiqgen is an expert in developing patient safety narratives. Our experienced writers and reviewers have several years of experience in authoring of safety narratives and regulatory documents.
Smiqgen understands that time is necessary for filing and obtaining the regulatory approval as delays in the process may lead to business loss. We are committed to providing you the best quality services delivered within the scheduled time.
Quality Control Review:
We offer in-depth quality control reviews of high standards that avoid the risk of rejection. We help in seeking regulatory approval for your product as early as possible.
Smiqgen offers comprehensive regulatory writing services under a single roof. We are experts in writing safety narratives, helping clients in authoring and reviewing of regulatory documents and periodic reports.
Multiple Therapeutic Areas:
Smiqgen works across several therapeutic areas managed by the best brains of the industry. The therapeutic areas we work include oncology, cardiovascular, metabolic disorders, and immunology.
We develop different strategies based on the requirement of clients, products, regulatory guidelines, and the best ways for obtaining early approval.
We are not just a regulatory writing services agency. We are your partners in successful regulatory approval.
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